Beckman Coulter Inc.
Medical device manufacturer in Brea, CA.
277510(k) clearances
5PMA approvals
554recalls
Device types
- GKZ Counter, Differential Cell 28
- LTT Panels, Test, Susceptibility, Antimicrobial 12
- JPK Mixture, Hematology Quality Control 10
- MMI Immunoassay Method, Troponin Subunit 10
- JJX Single (Specified) Analyte Controls… 9
- JIT Calibrator, Secondary 8
- LGD Enzyme Linked Immunoabsorbent Assay… 7
- JIS Calibrator, Primary 6
- JJY Multi-Analyte Controls, All Kinds (Assayed) 6
- MSW System, Test, Thyroglobulin 5
- CGN Acid, Folic, Radioimmunoassay 5
- LCP Assay, Glycosylated Hemoglobin 5
- OYE Flow Cytometric Reagents And Accessories. 5
- CGX Alkaline Picrate, Colorimetry, Creatinine 4
- CDD Radioassay, Vitamin B12 4
- JHX Fluorometric Method, Cpk Or Isoenzymes 4
- CFN Method, Nephelometric, Immunoglobulins (G… 4
- DDR Myoglobin, Antigen, Antiserum, Control 4
- CDZ Radioimmunoassay, Testosterones And… 4
- DCK C-Reactive Protein, Antigen, Antiserum, And… 4
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)LTT · Traditional | 07/18/2025SE |
| K242870 | Access hsTnIMMI · Traditional | 06/16/2025SE |
| K242022 | Access Toxo IgGLGD · Traditional | 03/28/2025SE |
| K242190 | Access Cortisol; DxC 500i Clinical AnalyzerCGR · Traditional | 03/05/2025SE |
| K242095 | Access Toxo IgM IILGD · Traditional | 10/11/2024SE |
| K241427 | Access SyphilisLIP · Traditional | 09/06/2024SE |
| K240469 | Access TPO AntibodyJZO · Traditional | 08/09/2024SE |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional | 07/05/2024SE |
| K240996 | Access Thyroglobulin Antibody IIJNL · Traditional | 07/03/2024SE |
| K240987 | Access sTfRDDG · Traditional | 07/03/2024SE |
| K240927 | Access ThyroglobulinMSW · Traditional | 06/28/2024SE |
| K241423 | Access ThyroglobulinMSW · Traditional | 06/07/2024SE |
| K240479 | Access OV MonitorLTK · Traditional | 05/10/2024SE |
| K240403 | Access BR MonitorMOI · Traditional | 05/09/2024SE |
| K240800 | Access Intrinsic Factor AbLIG · Traditional | 05/03/2024SE |
| K240182 | Access EPOGGT · Traditional | 04/22/2024SE |
| K232904 | Access OstaseCIN · Traditional | 04/15/2024SE |
| K232164 | Access NT-proBNPNBC · Traditional | 04/12/2024SE |
| K234052 | Access FerritinJMG · Traditional | 03/20/2024SE |
| K240273 | Access Free T4CEC · Traditional | 03/06/2024SE |
| K232791 | Access Intact PTHCEW · Traditional | 03/01/2024SE |
| K234005 | Access CK-MBJHX · Traditional | 02/16/2024SE |
| K233480 | Access SHBGCDZ · Traditional | 02/08/2024SE |
| K222881 | Access hsTnIMMI · Traditional | 12/18/2023SE |
| K230648 | Access hsTnIMMI · Traditional | 12/04/2023SE |
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C PanelsOYE · Traditional | 11/22/2023SE |
| K213517 | Access Thyroglobulin Antibody IIJZO · Traditional | 09/26/2023SE |
| K223921 | Access CEADHX · Traditional | 09/22/2023SE |
| K231832 | Access MyoglobinDDR · Traditional | 09/18/2023SE |
| K220972 | Access ThyroglobulinMSW · Traditional | 09/15/2023SE |
| K223590 | Access Folate AssayCGN · Traditional | 08/23/2023SE |
| K222996 | Access PCTPTF · Traditional | 04/26/2023SE |
| K221493 | MicroScan Prompt Inoculation System-DLIE · Traditional | 04/05/2023SE |
| K223038 | Access CortisolCGR · Traditional | 02/08/2023SE |
| K223679 | Access AMHPQO · Traditional | 02/03/2023SE |
| K223503 | Access 25(OH) Vitamin D TotalMRG · Traditional | 01/19/2023SE |
| K223405 | Access TestosteroneCDZ · Traditional | 01/13/2023SE |
| K221990 | Access Total ßhCG (5th IS)DHA · Traditional | 12/27/2022SE |
| K223289 | Access Vitamin B12CDD · Traditional | 12/23/2022SE |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerJLW · Traditional | 11/10/2022SE |
| K220178 | Total Immunoglobulin E (IgE)DGC · Traditional | 03/23/2022SE |
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemLKM · Traditional | 07/02/2021SE |
| K202423 | MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)JWY · Special | 05/18/2021SE |
| K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )LTT · Traditional | 11/16/2020SE |
| K201405 | LabPro Data Management SystemLON · Traditional | 08/30/2020SE |
| K201423 | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)LTT · Special | 06/29/2020SE |
| K193124 | Unicel DxH 800 Coulter Cellular Analysis SystemGKZ · Traditional | 04/16/2020SE |
| K193536 | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)LTT · Traditional | 03/18/2020SE |
| K193358 | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)LTT · Traditional | 03/03/2020SE |
| K192271 | Access PCT, Access PCT CalibratorsPTF · Traditional | 11/26/2019SE |
| K192355 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)JWY · Traditional | 11/14/2019SE |
| K182886 | Cytomics FC 500 Series (MPL or MCL) Flow CytometerGKZ · Traditional | 09/06/2019SE |
| K190109 | MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)JWY · Traditional | 04/18/2019SE |
| K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerPWD · Traditional | 03/21/2019SE |
| K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationQFS · Traditional | 03/18/2019SE |
| K181475 | DxH 520 Hematology InstrumentGKZ · Traditional | 03/01/2019SESU |
| K183127 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam…LTT · Traditional | 02/12/2019SE |
| K172787 | Access hsTnlMMI · Traditional | 06/14/2018SE |
| K172783 | Access hs TnlMMI · Traditional | 06/12/2018SE |
| K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4…LTT · Traditional | 12/15/2017SE |
| K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)LTT · Traditional | 12/07/2017SE |
| K172255 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 -…LTT · Traditional | 12/01/2017SE |
| K170524 | Access AMHPQO · Traditional | 11/13/2017SE |
| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…OYE · Traditional | 06/23/2017SE |
| K162740 | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)LTT · Traditional | 03/21/2017SE |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentCFN · Traditional | 01/09/2017SE |
| K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerJGS · Traditional | 12/16/2016SE |
| K162414 | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemGKZ · Special | 11/29/2016SE |
| K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay…JLW · Traditional | 08/18/2016SE |
| K152346 | MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)JWY · Special | 09/16/2015SE |
| K141932 | Aquios CL Flow Cytometer, Aquios TETRA-1 Panel,Aquios TETRA-2+PANEL, Aquios Immuno-Trol…OYE · Traditional | 04/10/2015SE |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL…JIT · Special | 02/26/2015SE |
| K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH)…MRG · Traditional | 12/22/2014SE |
| K142362 | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH)…MRG · Traditional | 12/19/2014SE |
| K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…CDD · Special | 09/16/2014SE |
| K140911 | Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter…GKZ · Abbreviated | 09/05/2014SE |
| K140829 | Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) ReagentLCP · Traditional | 07/14/2014SE |
| K131189 | Unicel DXC Synchron Systems Glucose Reagent (Gluh)CFR · Traditional | 04/17/2014SE |
| K130122 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman…CFN · Traditional | 01/07/2014SE |
| K130020 | Access Total BHCG (5TH Is)DHA · Traditional | 10/01/2013SE |
| K121790 | Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access Immunoassay…MMI · Traditional | 09/25/2013SE |
| K130373 | Navios Flow Cytometer SystemOYE · Traditional | 09/18/2013SE |
| K121445 | Tetrachrome Reagents and Tetracxp SystemOYE · Special | 07/26/2013SE |
| K130253 | Tq-Prep Workstation, Prepplus 2 WorkstationPER · Traditional | 07/15/2013SE |
| K121214 | Access ACCUTNI+3 Reagent and Access ACCUTN1+3 Calibrators for Use on the Access 2…MMI · Traditional | 06/14/2013SE |
| K120771 | Unicel DXH 800 Coulter Cellular Analysis SystemGKZ · Abbreviated | 03/22/2013SE |
| K120199 | Glycosylated Hemoglobin Assay; Clinical ChemistryLCP · Traditional | 10/12/2012SE |
| K121492 | Unicel DXC Synchron Systems Hemoglobin ALC-(HBA1C-) ReagentLCP · Special | 09/11/2012SE |
| K112933 | Access Thyroglobulin AnitbodyJNL · Special | 12/27/2011SE |
| K112412 | AU5800(R) Chemistry AnalyzerCEM · Traditional | 12/23/2011SE |
| K112603 | Access Hybritech P2PSA QC on the Access Immunoassay SystemsJJX · Abbreviated | 11/04/2011SE |
| K111952 | Access Folate Calibrators on the Access Immunoassay Systems Model A98033JIT · Abbreviated | 08/19/2011SE |
| K110251 | Synchron Multi CalibratorJIX · Traditional | 05/25/2011SE |
| K110413 | Power Processor Sample Processing System with Generic ConnectionsCDD · Special | 05/11/2011SE |
| K103842 | Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System…CGA · Traditional | 04/27/2011SE |
| K103373 | Synchron Systems Cholinesterase (Chex) Model A53722DIH · Traditional | 02/07/2011SE |
| K100790 | Coulter Lin-X Linearity Control, Model A81196JPK · Traditional | 12/21/2010SE |
| K100607 | Coulter 4C-EX 300 Cell ControlJPK · Traditional | 11/18/2010SE |
| K100010 | HDL Cholesterol (HDLX) AssayLBS · Traditional | 05/14/2010SE |
| K092505 | Beckman Coulter Ferritin Reagent, Model: OSR61203DBF · Traditional | 12/11/2009SE |
| K093458 | Synchron Systems Enzymatic Creatinine (Cr-E) Reagent, Model A60298JFY · Special | 12/04/2009SE |
| K091846 | Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607JFJ · Traditional | 10/16/2009SE |
| K083867 | Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin…CDZ · Traditional | 08/27/2009SE |
| K091742 | Synchron Systems Enzymatic Creatinine (Cr-E) Reagent, Model A60298JFY · Traditional | 08/14/2009SE |
| K091153 | Synchron Systems Enzymatic CO2 (CO2E) Reagent, Model A60291KHS · Traditional | 07/13/2009SE |
| K090588 | Power Processor Sample Processing System with Generic Connection Module, Model: 4210CDD · Traditional | 05/27/2009SE |
| K082251 | Synchron Systems Microalbumin (Ma) Reagent, Model 475100DCF · Traditional | 04/08/2009SE |
| K080481 | Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsDDR · Traditional | 02/20/2009SE |
| K082162 | Coulter Body Fluid ControlJPK · Traditional | 02/03/2009SE |
| K081822 | Coulter 6C Cell Control, Models 628027 & A59925JPK · Traditional | 01/21/2009SE |
| K081641 | Coulter Lin-X Linearity ControlJPK · Traditional | 01/16/2009SE |
| K081930 | Unicel DXH 800 Coulter Cellular Analysis SystemGKZ · Abbreviated | 12/19/2008SE |
| K081526 | Flowcare TLG ReagentGKZ · Abbreviated | 08/14/2008SE |
| K080634 | Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494…DDG · Traditional | 08/11/2008SE |
| K080812 | Hemoccult IctKHE · Traditional | 06/25/2008SE |
| K080869 | Access Toxo Igg, Access Toxo Igg Calibrators and Access Toxo Igg QCLGD · Traditional | 05/23/2008SE |
| K080166 | Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545JIT · Special | 03/19/2008SE |
| K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model(S) 387620,AND 387647MOI · Special | 10/26/2007SE |
| K071681 | Cytomics FC 500 MPL Flow Cytometer, Model # 626554GKZ · Special | 10/04/2007SE |
| K071002 | Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) ReagentNQD · Traditional | 06/21/2007SE |
| K071283 | Synchron Systems Creatinine ReagentCGX · Special | 06/01/2007SE |
| K071280 | Synchron CX Delta Clinical Systems, Creatinine Test SystemsCGX · Special | 06/01/2007SE |
| K071277 | Synchron LX20 Clinical Systems, Creatinine Test SystemsCGX · Special | 06/01/2007SE |
| K070626 | Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) ReagentNQD · Traditional | 05/04/2007SE |
| K070144 | Inhibin a Calibrators & Controls on the Access Immunoassay SystemsJIT · Traditional | 02/01/2007SE |
| K052223 | Access Epo AssayGGT · Abbreviated | 10/06/2006SE |
| K062516 | Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators)JNL · Special | 10/05/2006SE |
| K061616 | Coulter LH 780 Hematology AnalyzerGKZ · Abbreviated | 10/04/2006SE |
| K061190 | Access Intact PTH and Calibrators, Models a 16972 and a 16953CEW · Traditional | 09/15/2006SE |
| K061574 | Coulter LH 750 Hematology Analyzer, Model 6605632GKZ · Traditional | 07/21/2006SE |
| K061382 | Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227JZO · Traditional | 07/06/2006SE |
| K061282 | Access Ultrasensitive HGH Calibrator, Model 33585JIT · Special | 06/02/2006SE |
| K061064 | Coulter Lin-C Linearity Control, Models 7547065, 723503JPK · Traditional | 05/17/2006SE |
| K060935 | Synchron Systems Creatinine (Crea) ReagentCGX · Special | 04/28/2006SE |
| K053612 | Dri-Stat Acid Phosphatase ReagentCKB · Traditional | 04/26/2006SE |
| K060774 | Folate on the Access Immunoassay Systems, Model A14208CGN · Special | 04/21/2006SE |
| K060464 | Coulter 5C Cell ControlJPK · Traditional | 03/28/2006SE |
| K060256 | Unicel DXC 600I Synchron Access Clinical SystemCFR · Special | 02/27/2006SE |
| K060130 | Immage Systems Low Concentration Immunoglobulin a ReagentCZP · Special | 02/13/2006SE |
| K053090 | Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin CalibratorJFM · Traditional | 12/16/2005SE |
| K052905 | Modification to Coulter LH 750 Hematology AnalyzerGKZ · Special | 11/18/2005SE |
| K052082 | Ferritin on the Access Immunoassay Systems, Model 33020JMG · Special | 08/19/2005SE |
| K051122 | Itag MHC Tetramer CMV AssayGKZ · Traditional | 08/01/2005SE |
| K051307 | Synchron Systems Bebzodiazapine (Ebnz) ReagentJXM · Special | 06/13/2005SE |
| K050119 | Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by…JKM · Traditional | 05/06/2005SE |
| K043556 | Synchron Systems Benzodiazepine (BNZG) ReagentJXM · Traditional | 03/28/2005SE |
| K050057 | Coulter LH 750 Hematology AnalyzerGKZ · Special | 02/10/2005SE |
| K050202 | Cortisol and Cortisol Calibrators on the Access Immunoassay SystemsCGR · Special | 02/09/2005SE |
| K043215 | Flowcare PLG CD4 ReagentGKZ · Abbreviated | 01/19/2005SE |
| K042459 | Synchron LX Systems Hemoglobin A1C2 (HBA1C2) ReagentLCP · Traditional | 11/17/2004SE |
| K042291 | Unicel DXC 600 and 800 Synchron SystemsCEM · Traditional | 11/12/2004SE |
| K042724 | Modification to Coulter LH 500 Hematology AnalyzerGKZ · Special | 10/29/2004SE |
| K042173 | Coulter a T 5DIFF Cap Pierce (CP)GKZ · Abbreviated | 10/12/2004SE |
| K042651 | Free T3 Calibrators on the Access Immunoassay SystemsJIT · Traditional | 10/05/2004SE |
| K042281 | Modification to Access Hypersensitive HTSH AssayJLW · Special | 09/16/2004SE |
| K042195 | Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2…LBS · Traditional | 09/16/2004SE |
| K041643 | Synchron Systems Phosphorus (PHS) ReagentCEO · Traditional | 08/18/2004SE |
| K040767 | Synchron Systems HDL Cholesterol (HDLD) ReagentLBS · Traditional | 06/07/2004SE |
| K040181 | Access Dhea-S Reagent AssayJKC · Abbreviated | 03/24/2004SE |
| K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620…MOI · Traditional | 02/03/2004SE |
| K033038 | Gi Monitor and Gi Monitor Calibrators on the Access Immunoassay Systems, Model 387687…NIG · Traditional | 12/29/2003SE |
| K033603 | Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models…LIG · Traditional | 12/19/2003SE |
| K032342 | Coulter LH 750 Hematology AnalyzerGKZ · Abbreviated | 09/26/2003SE |
| K032287 | Modification to Synchron Systems Enzyme Validator Set Levels 1 and 2JIX · Special | 08/18/2003SE |
| K032000 | Coulter LH 500 Hematology AnalyzerGKZ · Abbreviated | 08/13/2003SE |
| K032162 | Access Immunoassay System Toxo Igg AssayLGD · Special | 08/08/2003SE |
| K032035 | Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…CZW · Traditional | 08/07/2003SE |
| K032013 | Coulter Act 5DIFF Al Hematology AnalyzerGKZ · Special | 07/24/2003SE |
| K031870 | Synchron Systems Valproic Acid (V-Pa) ReagentLEG · Special | 07/15/2003SE |
| K031606 | Access Immunoassay System Rubella Igg AssayLFX · Special | 06/20/2003SE |
| K031506 | Access Immunoassay System Toxo Igm II AssayLGD · Special | 06/02/2003SE |
| K030828 | Tetracxp System (Software and System Guide)GKZ · Abbreviated | 05/21/2003SE |
| K031270 | Access Cea Reagents for Use on the Access Immunoassay SystemsDHX · Special | 05/06/2003SE |
| K031297 | Access Ov Monitor AssayLTK · Special | 05/02/2003SE |
| K031269 | Access Thyroglobulin Reagents on the Access Immunoassay SystemsMSW · Special | 05/02/2003SE |
| K031002 | Synchron Systems Opiate ReagentDJG · Special | 04/29/2003SE |
| K030606 | Coulter LH 750 Body Fluids ApplicationGKZ · Abbreviated | 04/21/2003SE |
| K030291 | Coulter Act 5DIFF Autoloader (Al)GKZ · Abbreviated | 04/17/2003SE |
| K030408 | Cyto-Stat Tetrachrome CD45-FIT/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat…GKZ · Special | 03/04/2003SE |
| K024210 | Immage Systems Total Immunoglobulin E (Ige) Reagent Immage Ige CalibratorDGC · Traditional | 02/24/2003SE |
| K023764 | Unicel Dxi 800 Access Immunoassay System, Model 973100JJE · Traditional | 01/28/2003SE |
| K030012 | Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372JHX · Special | 01/17/2003SE |
| K023480 | Access Total BHCGJHI · Traditional | 12/20/2002SE |
| K023597 | Access Ov Monitor Immunoenzymetric AssayLTK · Traditional | 12/11/2002SE |
| K023369 | Access Total T4 AssayKLI · Traditional | 12/09/2002SE |
| K023093 | Access Hypersensitive HTSH AssayJLW · Traditional | 11/25/2002SE |
| K023048 | Modification to Synchron Systems Benzodiazepine ReagentJXM · Special | 11/07/2002SE |
| K023049 | Synchron LX I 725 Clinical SystemJGS · Special | 10/04/2002SE |
| K021814 | Accutni and Accutni Calibrators on the Access Immunoassay Systems, Model #33340, 33345MMI · Traditional | 09/27/2002SE |
| K022161 | Modification to Coulter LH 750 Hematology Analyzer, Model 6605632GKZ · Special | 07/29/2002SE |
| K021572 | Synchron Systems C-Reactive Protein (C-Rp) Reagent; Synchron Systems CX C-Rp CalibratorDCN · Traditional | 07/19/2002SE |
| K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…DDR · Traditional | 06/28/2002SE |
| K021150 | Coulter CellprepGKH · Traditional | 06/11/2002SE |
| K020521 | Modification to Vigil Lipid ControlJJY · Special | 03/01/2002SE |
| K014173 | Synchron Systems Salicylate Reagent and CalibratorDKJ · Traditional | 02/15/2002SE |
| K014103 | Synchron Systems Direct LDL Chloesterol Reagent and CalibratorMRR · Traditional | 01/28/2002SE |
| K013978 | Synchron Systems Pancreatic Amylase (Pam) ReagentJFJ · Traditional | 01/15/2002SE |
| K014034 | Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro)JFL · Special | 12/18/2001SE |
| K013842 | Immuno-Trol Low CellsJPK · Traditional | 12/13/2001SE |
| K013076 | Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin CalibratorLEH · Traditional | 12/12/2001SE |
| K013235 | Modification to Synchron ControlJJY · Special | 10/16/2001SE |
| K012900 | Access Unconjugated Estriol CalibratorsJIT · Traditional | 10/16/2001SE |
| K012208 | Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models…DDC · Traditional | 09/07/2001SE |
| K010748 | Synchron Systems Hemoglobin A1C ReagentLCP · Traditional | 07/10/2001SE |
| K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632GKZ · Traditional | 07/09/2001SE |
| K003259 | Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Model…LGD · Traditional | 06/13/2001SE |
| K011465 | Synchron CX Pro Clinical Systems, Model CX4 Pro, CX5 Pro, CX7 Pro, CX9 ProLDP · Special | 06/08/2001SE |
| K010429 | Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345MMI · Traditional | 06/05/2001SE |
| K010597 | Synchron LX Systems High Sensitivity C-Reactive Protien (CRPH) ReagentDCK · Traditional | 05/29/2001SE |
| K011213 | Modification to Synchron LX 20 Clinical Chemistry SystemJGS · Special | 05/16/2001SE |
| K010696 | Beckman Coulter Dnase B CalibratorJIS · Traditional | 05/10/2001SE |
| K010765 | Coulter HMX Analyzer, Model 6605523, Coulter HMX with Autoloader, Model 6605526GKZ · Special | 04/13/2001SE |
| K010693 | Vigil Dnase B ControlJJX · Traditional | 04/11/2001SE |
| K010236 | Immage Immunochemistry System High Sensitivity C-Reactive Protein (CRPH) ReagentDCK · Traditional | 04/05/2001SE |
| K010428 | Accutni QC on the Access Immunoassay System #33349JJX · Traditional | 03/13/2001SE |
| K010358 | Vigil Serology Control Level CJJY · Traditional | 03/05/2001SE |
| K010066 | 5C-ES Cell Control, Models 7547191, 7547192JPK · Special | 02/07/2001SE |
| K010064 | 4C-ES Cell, Models 7547187, 7547188, 7547189, 7547190JPK · Special | 02/07/2001SE |
| K003196 | Synchron Systems Ammonia ReagentJIF · Traditional | 12/22/2000SE |
| K003488 | Synchron ControlJJY · Special | 11/27/2000SE |
| K003098 | Access Ultrasensitive HGH CalibratorsJIT · Traditional | 11/20/2000SE |
| K002905 | Access Thyroglobulin Reagents on the Access AnalyzerMSW · Traditional | 10/19/2000SE |
| K002799 | Paragon Cze 2000 Capillary Electrophoresis System and BUFFER-100CFF · Special | 10/05/2000SE |
| K002453 | Access Toxo Igm II Reagents for Use on the Access Immunoassay Systems, Models 34470…LGD · Special | 08/31/2000SE |
| K001935 | Access Testosterone Reagents for Use on the Access Immunoassay Analyzer, Models 33560…CDZ · Traditional | 08/22/2000SE |
| K001458 | Synchron ControlJJX · Special | 06/02/2000SE |
| K000121 | Immage Immunochemistry System Lipoprotein(A) Lpax Reagent, Array System Lipoprotein(A)…DFC · Traditional | 05/17/2000SE |
| K000606 | Synchron Systems Amphetamine ReagentDKZ · Traditional | 05/05/2000SE |
| K000494 | Synchron Systems Acetaminophen (Actm) ReagentLDP · Traditional | 04/14/2000SE |
| K000410 | Synchron Systems Alcohol Reagent and CalibratorsDMT · Traditional | 04/10/2000SE |
| K994278 | Access Ostase Immunoenzymetric AssayCIN · Traditional | 03/28/2000SE |
| K000716 | Access Ck-Mb on the Access Immunoassay AnalyzerJHX · Special | 03/20/2000SE |
| K000196 | Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316DDR · Traditional | 02/18/2000SE |
| K000331 | Synchron LX Systems Microalbumin CalibratorJIS · Traditional | 02/10/2000SE |
| K994169 | Synchron CX Systems Prealbumin CalibratorJIS · Traditional | 02/03/2000SE |
| K994168 | Synchron LX Systems Prealbumin CalibratorJIS · Traditional | 02/03/2000SE |
| K993549 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc)…CFN · Traditional | 02/01/2000SE |
| K993547 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc)…CFN · Traditional | 02/01/2000SE |
| K994200 | Access Hybritech Psa QC, Model 37209JJX · Traditional | 01/18/2000SE |
| K994439 | Access Ck-Mb on the Access Immunoassay Analyzer, Models 33300, 33305, 33309, 33306JHX · Traditional | 01/14/2000SE |
| K994277 | Access Ostase QCJJX · Traditional | 01/14/2000SE |
| K994325 | Synchron CX Systems Microalbumin CalibratorJIS · Traditional | 01/12/2000SE |
| K993954 | Synchron Systems Dat Multi-Drug Low and High Urine CalibratorsDKB · Traditional | 01/11/2000SE |
| K993210 | Access Hybritech Free Psa QC, Model 37219JJX · Traditional | 01/05/2000SE |
| K993473 | Synchron Systems Drug Calibrator 2DLJ · Traditional | 11/26/1999SE |
| K993023 | Synchron Systems Op 300 Low and High Urine ControlsJJY · Traditional | 11/26/1999SE |
| K993022 | Synchron Systems Op 300 Low and High Urine CalibratorsDLJ · Traditional | 11/09/1999SE |
| K990704 | Array 360 System C-Reactive Protein (CRP Mpe) ReagentDCK · Traditional | 05/03/1999SE |
| K984402 | Synchron Systems Ammonia (Amm) ReagentJIF · Traditional | 01/29/1999SE |
| K984152 | Synchron Systems Opiates 2000 NG (OP2) ReagentDJG · Traditional | 01/29/1999SE |
| K983747 | Synchron Systems Dat Low and High Urine Calibrators IIDKB · Traditional | 12/30/1998SE |
| K984014 | Synchron Systems Enzyme Validator Set Levels 1 and 2JIX · Traditional | 12/23/1998SE |
| K983640 | Synchron Systems Lipid CalibratorJIS · Traditional | 12/21/1998SE |
| K983340 | Immage Immunochemistry System Ferritin (Fer)Reagent, Immage Immunochemistry System…DBF · Traditional | 12/14/1998SE |
| K983895 | Immage Immunochemistry System BETA-2 Microglobulin ReagentJZG · Traditional | 11/25/1998SE |
| K983151 | Immage Immunochemistry System Digoxin (Dig) ReagentKXT · Traditional | 11/05/1998SE |
| K983209 | Synchron Systems Dat Low and High Urine Calibrators IDKB · Traditional | 11/04/1998SE |
| K983709 | Synchron Systems Dat Low and High Urine Controls 1DIF · Traditional | 10/28/1998SE |
| K982935 | Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug CalibratorKXT · Traditional | 10/14/1998SE |
| K981985 | Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209DHX · Traditional | 09/24/1998SE |
| K982224 | Vigil Protein ControlJJY · Traditional | 07/09/1998SE |
| K982022 | Vigil Hemoglobin (Hbalc) ControlsJJX · Traditional | 07/06/1998SE |
| K981864 | Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219JJX · Traditional | 06/12/1998SE |
| K981638 | Immage Immunochemistry System C-Reactive Protein (CRP) ReagentDCK · Traditional | 06/12/1998SE |
| K955434 | Access Folate Assay (Modification)CGN · Traditional | 01/29/1996SE |
| K943149 | Access Red Blood Cell Folate AssayCGN · Traditional | 08/26/1994SE |
| K932887 | Access Folate AssayCGN · Traditional | 10/12/1993SE |
PMA approvals
- P230015 Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC · 10/17/2025 · 0 supplements
- P090026 Access Hybritech P2PSA on the Access Immunoassay Systems · 06/14/2012 · 28 supplements
- P980041 Access Afp Immunoassay System · 02/08/1999 · 47 supplements
- P970038 Tandem-R Free Psa Immunoradiometric Assay/Tandem-Mp Free Psa Immunoenzymetric Assay · 03/10/1998 · 42 supplements
- P850048 Tandem-R Psa Immunoradiometric Assay · 02/25/1986 · 55 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-2974-2026 Class II | Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or…a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test… | 07/15/2026Open, Classified |
| Z-2973-2026 Class II | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower:…a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test… | 07/15/2026Open, Classified |
| Z-2889-2026 Class II | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following…Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading… | 06/26/2026Open, Classified |
| Z-2888-2026 Class II | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the…Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading… | 06/26/2026Open, Classified |
| Z-1922-2026 Class II | Access Total T4 Calibrator, Catalog No. 33805Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on… | 03/16/2026Open, Classified |
| Z-1235-2026 Class II | CellMek SPS Sample Preparation System, REF: C44603, with softwareSample preparation system designed to automate staining, lysing, cell washing has a software error that… | 12/23/2025Open, Classified |
| Z-1026-2026 Class II | Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288…Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may… | 11/26/2025Open, Classified |
| Z-1025-2026 Class II | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay…Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may… | 11/26/2025Open, Classified |
| Z-1221-2026 Class II | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an…Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with… | 11/10/2025Open, Classified |
| Z-0889-2026 Class II | Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process…It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities.… | 11/07/2025Open, Classified |
| Z-0429-2026 Class II | Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry…An internal investigation has determined that due to defective sub-components within the gantry assembly, a… | 10/01/2025Open, Classified |
| Z-0428-2026 Class II | Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry…An internal investigation has determined that due to defective sub-components within the gantry assembly, a… | 10/01/2025Open, Classified |
| Z-0541-2026 Class II | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow…Due to a software error code that crashes during acquisition on patient sample when running customer defined… | 09/22/2025Open, Classified |
| Z-0216-2026 Class II | DxI 9000 Access Immunoassay Analyzer, Part Number C11137Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i… | 09/19/2025Open, Classified |
| Z-0215-2026 Class II | DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number…Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i… | 09/19/2025Open, Classified |
| Z-0441-2026 Class II | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL… | 09/17/2025Open, Classified |
| Z-1794-2026 Class II | MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended…Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. | 09/08/2025Open, Classified |
| Z-0412-2026 Class II | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and…Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device… | 09/08/2025Open, Classified |
| Z-0071-2026 Class II | SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx…Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration… | 09/03/2025Open, Classified |
| Z-2575-2025 Class II | UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer…Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results… | 08/13/2025Open, Classified |
| Z-2574-2025 Class II | UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer…Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results… | 08/13/2025Open, Classified |
| Z-2573-2025 Class II | UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer…Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results… | 08/13/2025Open, Classified |
| Z-2572-2025 Class II | UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer…Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results… | 08/13/2025Open, Classified |
| Z-0032-2026 Class II | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC…On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an… | 08/04/2025Open, Classified |
| Z-1609-2026 Class II | MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are…Due to the likely presence of contamination in well(s). | 07/24/2025Open, Classified |
| Z-2322-2025 Class II | Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog…Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased… | 07/10/2025Open, Classified |
| Z-2264-2025 Class II | UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their… | 06/26/2025Open, Classified |
| Z-2271-2025 Class II | DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running… | 06/25/2025Open, Classified |
| Z-2270-2025 Class II | DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running… | 06/25/2025Open, Classified |
| Z-2269-2025 Class II | UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running… | 06/25/2025Open, Classified |
| Z-2268-2025 Class II | DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running… | 06/25/2025Open, Classified |
| Z-2267-2025 Class II | DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running… | 06/25/2025Open, Classified |
| Z-2266-2025 Class II | UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running… | 06/25/2025Open, Classified |
| Z-1772-2026 Class II | MicroScan Neg MIC 3J REF C54814Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics | 06/25/2025Open, Classified |
| Z-2152-2025 Class II | Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement…A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included… | 06/12/2025Open, Classified |
| Z-1996-2025 Class II | DxI 9000 Access Immunoassay Analyzer C11137Analyzer has calibration issues where curves switched from passed to failed due to system errors during… | 05/07/2025Open, Classified |
| Z-1901-2025 Class II | Access Testosterone assay, Catalog Number 33560Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing… | 05/05/2025Open, Classified |
| Z-1926-2025 Class II | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions…A new motor/encoder and cable was introduced into instruments manufactured starting with serial number… | 04/23/2025Open, Classified |
| Z-1913-2025 Class II | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from… | 04/23/2025Open, Classified |
| Z-2028-2025 Class II | REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488…Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the… | 04/08/2025Open, Classified |
| Z-1664-2025 Class II | Beckman Coulter DxI 9000 Access Immunoassay AnalyzerWhen DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS)… | 03/27/2025Open, Classified |
| Z-1784-2025 Class II | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 /…Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes… | 03/20/2025Open, Classified |
| Z-1672-2025 Class II | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 /…The reason for the recall is incorrect sample barcode identification and processing errors that result in… | 03/17/2025Open, Classified |
| Z-2115-2025 Class II | Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12… | 02/27/2025Completed |
| Z-1517-2025 Class II | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 /…Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a… | 02/26/2025Open, Classified |
| Z-1387-2025 Class II | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI…Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage… | 02/06/2025Open, Classified |
| Z-1388-2025 Class II | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and… | 02/05/2025Open, Classified |
| Z-1386-2025 Class II | Access 2 Immunoassay Analyzer, Catalog Number 81600NBeckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment… | 02/05/2025Open, Classified |
| Z-1249-2025 Class II | Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons)…Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to… | 02/03/2025Open, Classified |
| Z-1112-2025 Class II | Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl…Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max… | 01/02/2025Open, Classified |
| Z-0803-2025 Class II | Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the…Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or… | 11/26/2024Open, Classified |
| Z-0727-2025 Class II | Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the…Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for… | 11/18/2024Open, Classified |
| Z-1326-2025 Class II | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley… | 11/13/2024Open, Classified |
| Z-0673-2025 Class II | Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number…The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000… | 11/08/2024Open, Classified |
| Z-0313-2025 Class II | The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for…The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at… | 09/30/2024Open, Classified |
| Z-0265-2025 Class II | Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF…IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in… | 09/05/2024Open, Classified |
| Z-0094-2025 Class II | The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay…Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone)… | 08/28/2024Open, Classified |
| Z-0118-2025 Class II | IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when…Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU | 07/31/2024Open, Classified |
| Z-0093-2025 Class III | Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211…Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative… | 07/16/2024Open, Classified |
| Z-1529-2025 Class II | DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device…Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying… | 07/12/2024Open, Classified |
| Z-3180-2024 Class II | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic…Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in… | 07/10/2024Open, Classified |
| Z-2545-2024 Class II | Discrete photometric chemistry analyzer for clinical use.Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System… | 06/14/2024Open, Classified |
| Z-2414-2024 Class II | Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold… | 06/04/2024Open, Classified |
| Z-2428-2024 Class II | Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as… | 05/27/2024Open, Classified |
| Z-2735-2024 Class II | DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is… | 05/22/2024Open, Classified |
| Z-2544-2024 Class II | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay… | 05/22/2024Open, Classified |
| Z-2264-2024 Class II | DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnosticBeckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used… | 04/18/2024Open, Classified |
| Z-0025-2025 Class II | Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro…When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to… | 04/18/2024Open, Classified |
| Z-1546-2024 Class II | DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the…Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash… | 03/05/2024Open, Classified |
| Z-2237-2024 Class II | Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry…The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable… | 02/29/2024Open, Classified |
| Z-1303-2024 Class II | Access Total T4, REF 33800, IVD, thyroxine reagent assay.Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which… | 02/08/2024Open, Classified |
| Z-1376-2024 Class II | Access Substrate, REF 81906, For use with the Access Immunoassay SystemsOn 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906)… | 02/07/2024Open, Classified |
| Z-1115-2025 Class II | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro…A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a… | 01/03/2024Completed |
| Z-0787-2024 Class II | iQ Waste Well Adapter, Part Number: 700-3393Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse… | 12/19/2023Open, Classified |
| Z-0786-2024 Class II | REV 2 Flowcell Capsule Spare, Part Number: C04154Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse… | 12/19/2023Open, Classified |
| Z-0785-2024 Class II | iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c)…Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse… | 12/19/2023Open, Classified |
| Z-0784-2024 Class II | Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse… | 12/19/2023Open, Classified |
| Z-0982-2024 Class II | DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1)… | 11/21/2023Open, Classified |
| Z-0981-2024 Class II | Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer…There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000… | 11/21/2023Open, Classified |
| Z-0107-2024 Class II | DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below…The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System… | 09/12/2023Open, Classified |
| Z-2488-2023 Class II | Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2Lipemic interference failed to meet the performance specification listed within the IFU. | 07/12/2023Open, Classified |
| Z-0100-2024 Class II | Access Thyroglobulin CalibratorsIt has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator… | 07/06/2023Open, Classified |
| Z-2237-2023 Class II | Ringed DxI Reaction Vessels (RVs)Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay… | 06/20/2023Open, Classified |
| Z-2138-2023 Class II | COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cellsSpecific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing… | 05/31/2023Open, Classified |
| Z-2043-2023 Class II | Access Hybritech p2PSA reagent, REF B03704 and REF A49752.Reagent lot numbers include an insufficient concentration of blocking reagent. | 05/17/2023Open, Classified |
| Z-1608-2023 Class II | Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mLThere is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in… | 04/05/2023Open, Classified |
| Z-1607-2023 Class II | Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mLThere is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in… | 04/05/2023Open, Classified |
| Z-1606-2023 Class II | Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mLThere is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in… | 04/05/2023Open, Classified |
| Z-1599-2023 Class II | UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysisBeckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had… | 04/05/2023Open, Classified |
| Z-1598-2023 Class II | DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic…Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had… | 04/05/2023Open, Classified |
| Z-1597-2023 Class II | DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic…Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had… | 04/05/2023Open, Classified |
| Z-1596-2023 Class II | iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and…Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had… | 04/05/2023Open, Classified |
| Z-1419-2023 Class II | Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box…The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not… | 03/15/2023Open, Classified |
| Z-1257-2023 Class II | Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2…An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume… | 01/26/2023Open, Classified |
| Z-0777-2023 Class II | BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB… | 11/18/2022Open, Classified |
| Z-0269-2023 Class II | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. | 10/03/2022Open, Classified |
| Z-0984-2022 Class III | Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL…IRISpec CA failures for glucose. | 02/16/2022Open, Classified |
| Z-0692-2022 Class II | AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in… | 12/08/2021Terminated |
| Z-0399-2022 Class II | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors.… | 11/10/2021Open, Classified |
| Z-0032-2022 Class II | Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT…Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL… | 08/09/2021Open, Classified |
| Z-2508-2021 Class II | Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF…Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA… | 08/05/2021Terminated |
| Z-0117-2022 Class II | Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig)…Missing splash guard which may expose users to hazardous materials. . | 07/28/2021Open, Classified |
| Z-2602-2021 Class II | DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference…There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport… | 07/21/2021Terminated |
| Z-2332-2021 Class II | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a…There is a potential that the data management system may add additional cells to the patient request which… | 07/15/2021Terminated |
| Z-2258-2021 Class II | ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN…SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . | 07/01/2021Terminated |
| Z-2257-2021 Class II | ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1…SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . | 07/01/2021Terminated |
| Z-2256-2021 Class II | Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0…SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . | 07/01/2021Terminated |
| Z-2255-2021 Class II | ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . | 07/01/2021Terminated |
| Z-2241-2021 Class II | Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C…Software anomalies that may lead to the generation of erroneous results. | 06/23/2021Terminated |
| Z-1906-2021 Class II | Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running… | 05/07/2021Terminated |
| Z-1905-2021 Class II | Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running… | 05/07/2021Terminated |
| Z-1670-2021 Class II | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70…specimens collected in transport media may result is false negative results when stored in certain conditions. | 04/14/2021Terminated |
| Z-0875-2021 Class II | ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access…The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the… | 12/30/2020Terminated |
| Z-0720-2021 Class II | MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial…Due to a customer report and internal investigation, it was confirmed that a portion of the affected product… | 12/02/2020Terminated |
| Z-3006-2020 Class II | BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol… | 08/26/2020Terminated |
| Z-3028-2020 Class II | UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317…The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will… | 08/18/2020Terminated |
| Z-1945-2020 Class II | iQ200 Series Urine Microscopy Analyzer- All part numbersA defect in the SATA power adapter cable within the instrument s computer has the potential risk for an… | 03/30/2020Terminated |
| Z-1944-2020 Class II | iChemVELOCITY Urine Chemistry System-A defect in the SATA power adapter cable within the instruments computer has the potential risk for an… | 03/30/2020Terminated |
| Z-1535-2020 Class II | iChemVELOCITY Strips, Catalog 800-7212The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY… | 02/17/2020Terminated |
| Z-2136-2020 Class II | ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product…Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or… | 01/29/2020Terminated |
| Z-1673-2020 Class II | LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data…A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7… | 01/17/2020Terminated |
| Z-1674-2020 Class II | Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI:…Due to customer reports it has been determined that the inoculation system contains the incorrect prompt… | 12/13/2019Terminated |
| Z-0843-2020 Class II | iChem VELOCITY Urine Chemistry AnalyzerBeckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the… | 11/07/2019Terminated |
| Z-0914-2020 Class II | iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325…Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen… | 10/28/2019Terminated |
| Z-0913-2020 Class II | iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001…Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen… | 10/28/2019Terminated |
| Z-1088-2022 Class II | MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396RWalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated… | 10/21/2019Open, Classified |
| Z-1087-2022 Class II | MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340RWalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated… | 10/21/2019Open, Classified |
| Z-1086-2022 Class II | DxM 1096 MicroScan WalkAway Instrument REF B1018-496WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated… | 10/21/2019Open, Classified |
| Z-1085-2022 Class II | DxM 1040 MicroScan WalkAway Instrument REF B1018-440WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated… | 10/21/2019Open, Classified |
| Z-1084-2022 Class II | MicroScan WalkAway-96 plus Instrument REF B1018-284WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated… | 10/21/2019Open, Classified |
| Z-1083-2022 Class II | MicroScan WalkAway-40 plus Instrument REF B1018-283WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated… | 10/21/2019Open, Classified |
| Z-0516-2020 Class II | UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS…When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent… | 10/07/2019Terminated |
| Z-1752-2020 Class II | Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800…Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use.… | 09/04/2019Terminated |
| Z-1751-2020 Class II | Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in…Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use.… | 09/04/2019Terminated |
| Z-1373-2021 Class II | MicroScan WalkAway-96 plus Reconditioned InstrumentInstruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not… | 09/04/2019Terminated |
| Z-1372-2021 Class II | MicroScan WalkAway-40 plus Reconditioned InstrumentInstruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not… | 09/04/2019Terminated |
| Z-1371-2021 Class II | MicroScan WalkAway-96 plus InstrumentInstruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not… | 09/04/2019Terminated |
| Z-1370-2021 Class II | MicroScan WalkAway-40 plus InstrumentInstruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not… | 09/04/2019Terminated |
| Z-1426-2020 Class II | Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300…It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen… | 08/15/2019Terminated |
| Z-1425-2020 Class II | Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200…It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen… | 08/15/2019Terminated |
| Z-1424-2020 Class II | Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only…It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen… | 08/15/2019Terminated |
| Z-1423-2020 Class II | Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only…It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen… | 08/15/2019Terminated |
| Z-1422-2020 Class II | Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx…It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen… | 08/15/2019Terminated |
| Z-1799-2020 Class II | SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product…The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates… | 06/12/2019Terminated |
| Z-1741-2020 Class II | Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog…Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload… | 05/17/2019Terminated |
| Z-2242-2020 Class II | Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898…The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all… | 04/30/2019Terminated |
| Z-2241-2020 Class II | Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF…The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all… | 04/30/2019Terminated |
| Z-2240-2020 Class II | Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI:…The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all… | 04/30/2019Terminated |
| Z-2239-2020 Class II | Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830…The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all… | 04/30/2019Terminated |
| Z-2238-2020 Class II | Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422…The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all… | 04/30/2019Terminated |
| Z-2237-2020 Class II | Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880…The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all… | 04/30/2019Terminated |
| Z-1078-2019 Class II | UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are…When racks are front-loaded onto the sample presentation unit while samples from the automation line are… | 12/05/2018Open, Classified |
| Z-1077-2019 Class II | The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an…When racks are front-loaded onto the sample presentation unit while samples from the automation line are… | 12/05/2018Open, Classified |
| Z-0492-2020 Class II | AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125…Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a… | 11/09/2018Open, Classified |
| Z-1937-2019 Class II | iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name…Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the… | 10/18/2018Terminated |
| Z-2763-2019 Class II | The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic…Cross contamination may have occurred between wells for the reagent pack. As a result of this defect… | 09/18/2018Terminated |
| Z-1982-2019 Class II | Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the…Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility… | 09/17/2018Terminated |
| Z-0211-2020 Class II | Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at… | 08/24/2018Terminated |
| Z-0210-2020 Class II | Beckman Coulter Lipase, REF OSR6130 and OSR6230.NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at… | 08/24/2018Terminated |
| Z-1384-2019 Class I | UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note:…Complaints received of sporadic erroneously elevated platelet results without flags or system messages.… | 07/30/2018Terminated |
| Z-1383-2019 Class I | UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note:…Complaints received of sporadic erroneously elevated platelet results without flags or system messages.… | 07/30/2018Terminated |
| Z-1382-2019 Class I | UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802…Complaints received of sporadic erroneously elevated platelet results without flags or system messages.… | 07/30/2018Terminated |
| Z-0359-2019 Class III | Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |
| Z-0358-2019 Class III | Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |
| Z-0357-2019 Class III | Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |
| Z-0356-2019 Class III | Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |
| Z-0355-2019 Class III | Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No.…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the… | 05/24/2018Terminated |
| Z-0354-2019 Class III | Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which included the… | 05/24/2018Terminated |
| Z-0353-2019 Class III | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software…Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW and the… | 05/24/2018Terminated |
| Z-2599-2018 Class II | MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining…The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC… | 05/04/2018Terminated |
| Z-1894-2018 Class II | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem…The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for… | 03/29/2018Terminated |
| Z-1804-2018 Class II | BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3%…Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for… | 03/26/2018Terminated |
| Z-1643-2018 Class II | BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530…Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North… | 03/02/2018Terminated |
| Z-1362-2018 Class II | BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345…Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per… | 03/02/2018Terminated |
| Z-1341-2018 Class II | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is…The device may process the same sample with two different sample IDs and sample information while using the… | 01/29/2018Terminated |
| Z-1169-2018 Class II | AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate…Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature… | 01/19/2018Completed |
| Z-1151-2018 Class II | AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog…A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip… | 01/18/2018Terminated |
| Z-0472-2019 Class I | COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II SoftwareA manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal… | 01/12/2018Terminated |
| Z-0471-2019 Class I | 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP…A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal… | 01/12/2018Terminated |
| Z-1893-2018 Class II | iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY…A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the… | 12/04/2017Terminated |
| Z-1366-2018 Class II | iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s:…iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels… | 11/10/2017Terminated |
| Z-0310-2018 Class III | UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic…Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when… | 11/06/2017Terminated |
| Z-0309-2018 Class III | Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic…Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when… | 11/06/2017Terminated |
| Z-0308-2018 Class III | Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for…Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when… | 11/06/2017Terminated |
| Z-0238-2018 Class II | UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology…The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the… | 11/03/2017Terminated |
| Z-0237-2018 Class II | UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is…The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the… | 11/03/2017Terminated |
| Z-0236-2018 Class II | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzerThe shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the… | 11/03/2017Terminated |
| Z-0091-2018 Class II | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman…The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory… | 10/02/2017Terminated |
| Z-0605-2018 Class II | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry…Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1… | 08/24/2017Terminated |
| Z-3135-2017 Class II | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an…Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can… | 08/21/2017Terminated |
| Z-0046-2018 Class II | Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample…Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a… | 08/03/2017Terminated |
| Z-3118-2017 Class II | Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on…Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated… | 07/20/2017Terminated |
| Z-3114-2017 Class II | Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer…Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In… | 06/26/2017Terminated |
| Z-3113-2017 Class II | Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are…Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In… | 06/26/2017Terminated |
| Z-3101-2017 Class II | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2.…The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after… | 06/20/2017Terminated |
| Z-2690-2017 Class II | Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used…When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow… | 05/22/2017Terminated |
| Z-2689-2017 Class II | Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a…When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow… | 05/22/2017Terminated |
| Z-2730-2017 Class II | Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the…The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when… | 05/15/2017Terminated |
| Z-2638-2017 Class II | Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687The Access immunoassays are susceptible to biotin interference. | 05/09/2017Terminated |
| Z-2637-2017 Class II | Access System-Free T4 Assay, B01902E, Catalog No. 33880The Access immunoassays are susceptible to biotin interference. | 05/09/2017Terminated |