Counter, Differential Cell
FDA product code GKZ · Class II (moderate risk) · 21 CFR 864.5220 · Hematology
380510(k) clearances
0PMA approvals
217recalls
Manufacturers
- Beckman Coulter Inc. 28
- Abbott Laboratories 24
- Coulter Corp. 23
- Sysmex America, Inc. 22
- Becton Dickinson Immunocytometry Systems 21
- Ortho Diagnostic Systems, Inc. 16
- Bd Becton Dickinson Vacutainer Systems Preanalytic 15
- Dako Corp. 14
- Coulter Electronics, Inc. 14
- Coulter Immunology 14
- Toa Medical Electronics USA, Inc. 11
- Caltag Laboratories, Inc. 11
- Geometric Data, Div. Smithkline Corp. 11
- Abx Diagnostics 9
- Bd Biosciences 9
- Immunotech Corp. 6
- Abbott Diagnostics 6
- Technicon Instruments Corp. 6
- Horiba Abx 6
- Gen Trak, Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | Sysmex America, Inc. | 05/27/2026SE |
| K243348 | Athelas HomeGKZ · Traditional | Athelas, Inc. | 02/06/2026SE |
| K251249 | Tru Hematology TestGKZ · Traditional | Truvian Sciences, Inc. | 01/16/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 06/25/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | Abbott Laboratories | 02/20/2025SE |
| K240402 | Cito CBC SystemGKZ · Dual Track | Cytochip, Inc. | 02/03/2025SE |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…GKZ · Traditional | Beckman Coulter, Inc. | 07/05/2024SE |
| K232946 | Yumizen H2500GKZ · Traditional | Horiba Abx SAS | 05/21/2024SE |
| K240636 | HemoScreen Hematology AnalyzerGKZ · Abbreviated | Pixcell Medical Technologies | 05/02/2024SE |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 12/21/2023SE |
| K230878 | QScout Lab; QScout RLDGKZ · Traditional | Ad Astra Diagnostics, Inc. | 11/14/2023SE |
| K222148 | HemoScreen Hematology AnalyzerGKZ · Traditional | Pixcell Medical Technologies, Ltd. | 08/16/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | Abbott Laboratories | 08/04/2023SE |
| K210346 | Sysmex XW-100 Automated Hematology AnalyzerGKZ · Dual Track | Sysmex America, Inc. | 11/08/2022SE |
| K211840 | Sight OLOGKZ · Traditional | S.D. Sight Diagnostics , Ltd. | 05/09/2022SE |
| K200828 | Athelas HomeGKZ · Traditional | Athelas, Inc. | 03/22/2022SE |
| K193124 | Unicel DxH 800 Coulter Cellular Analysis SystemGKZ · Traditional | Beckman Coulter | 04/16/2020SE |
| K190898 | Sight OLOGKZ · Traditional | Sight Diagnostics , Ltd. | 11/01/2019SE |
| K182886 | Cytomics FC 500 Series (MPL or MCL) Flow CytometerGKZ · Traditional | Beckman Coulter | 09/06/2019SE |
| K190294 | CELL-DYN Emerald 22 AL SystemGKZ · Special | Abbott Laboratories | 03/15/2019SE |
| K181475 | DxH 520 Hematology InstrumentGKZ · Traditional | Beckman Coulter | 03/01/2019SESU |
| K182389 | Sysmex XN-L Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 01/25/2019SE |
| K181288 | Athelas OneGKZ · Traditional | Athelas, Inc. | 11/05/2018SE |
| K180020 | HemoScreen Hematology AnalyzerGKZ · Traditional | Pixcell Medical Technologies, Ltd. | 10/29/2018SE |
| K171655 | cobas m 511 integrated hematology analyzerGKZ · Traditional | Roche Diagnostics Hematology, Inc. | 03/02/2018SE |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ · Dual Track | Sysmex America, Inc. | 11/06/2017SE |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CTGKZ · Traditional | Horiba Abx SAS | 11/01/2017SE |
| K162977 | ADVIA 2120i, ADVIA 2120GKZ · Traditional | Siemens Healthcare Diagnostics | 08/11/2017SE |
| K153538 | Dextramer CMV KitGKZ · Traditional | Immudex Aps | 03/02/2017SE |
| K160538 | Sysmex XN-L Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 12/22/2016SE |
| K162414 | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemGKZ · Special | Beckman Coulter, Inc. | 11/29/2016SE |
| K160429 | BC-5390 Auto Hematology AnalyzerGKZ · Traditional | Mindray Bio-Medical Electronics Co., Ltd. | 09/01/2016SE |
| K151133 | Pentra XLRGKZ · Traditional | Horiba Abx SAS | 12/09/2015SE |
| K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECKGKZ · Traditional | Sysmex America, Inc. | 10/12/2015SE |
| K143348 | BC-3600 Auto Hematology AnalyzerGKZ · Traditional | Mindray Bio-Medical Electronics Co., Ltd. | 08/21/2015SE |
| K141161 | Abx Micros Es 60 CT; (Open Tube Model), (Close Tube Model)GKZ · Traditional | Horiba Abx SAS | 12/20/2014SE |
| K141681 | Sysmex XN SeriesGKZ · Traditional | Sysmex America, Inc. | 12/05/2014SE |
| K140911 | Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter…GKZ · Abbreviated | Beckman Coulter, Inc. | 09/05/2014SE |
| K120771 | Unicel DXH 800 Coulter Cellular Analysis SystemGKZ · Abbreviated | Beckman Coulter, Inc. | 03/22/2013SE |
| K112605 | Sysmex Xn-SeriesGKZ · Traditional | Sysmex America, Inc. | 10/19/2012SE |
| K111534 | Abacus 3CPGKZ · Traditional | Diatron U.S., Inc. | 08/02/2012SE |
| K112755 | Abacus 5GKZ · Traditional | Diatron U.S., Inc. | 03/27/2012SE |
| K110381 | Cell-Dyn Emerald 22 SystemGKZ · Traditional | Abbott Laboratories | 12/22/2011SE |
| K102644 | Advia 2120 with Autoslide System, and Advia 2120IGKZ · Traditional | Siemens Healthcare Diagnostics | 11/23/2011SE |
| K102064 | BD Facs Sample Prep Assistant III (SPA III)GKZ · Traditional | Becton, Dickinson & CO | 03/07/2011SE |
| K100489 | DXH 300 Coulter Cellular Analysis System, DXH 300C Coulter Cellular Analyssi System…GKZ · Traditional | Beckman Coulter Cellular | 10/26/2010SE |
| K090346 | Advia 2120/2120I Body FluidsGKZ · Traditional | Siemens Healthcare Diagnostics | 07/28/2010SE |
| K093394 | BC-3200 Auto Hematology ANALYZER,M-30D Diluent, M-30R Rinse, M-30CFL Lyse, M-30E-Z…GKZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/08/2010SE |
| K091313 | Sysmex Model XT-4000IGKZ · Traditional | Sysmex America, Inc. | 03/30/2010SE |
| K090810 | Thermo Scientific Cyto-Cal Count TubesGKZ · Traditional | Microgenics Corp. | 09/18/2009SE |
| K090967 | BD Multitest 6-COLOR TBNK Reagent, Model 644611GKZ · Traditional | Bd Biosciences | 07/31/2009SE |
| K090013 | Chempaq XBC AnalyzerGKZ · Special | Chempaq A/S | 04/21/2009SE |
| K082091 | Tri T-Stat Reagent Assay (Dried Form) Model 25107-00GKZ · Traditional | Reametrix, Inc. | 04/15/2009SE |
| K081495 | Cell-Dyn Emerald SystemGKZ · Traditional | Abbott Laboratories | 02/04/2009SE |
| K083420 | Medonic M SeriesGKZ · Special | Boule Medical AB | 02/03/2009SE |
| K081930 | Unicel DXH 800 Coulter Cellular Analysis SystemGKZ · Abbreviated | Beckman Coulter, Inc. | 12/19/2008SE |
| K081890 | Sysmex Xt-Series Ig Parameter,Sysmex Xt-Series Ret-He ParameterGKZ · Traditional | Sysmex America, Inc. | 10/10/2008SE |
| K081610 | Sysmex Model XS-1000IC Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 08/29/2008SE |
| K081526 | Flowcare TLG ReagentGKZ · Abbreviated | Beckman Coulter, Inc. | 08/14/2008SE |
| K081213 | BD Facscount CD4 Reagents with Model 339010GKZ · Traditional | Bd Biosciences | 08/14/2008SE |
| K072869 | Pointcare Now SystemGKZ · Traditional | Pointcare Technologies, Inc. | 01/14/2008SE |
| K071562 | D3 Hematology Analyzer, Model D3GKZ · Traditional | Drew Scientific, Inc. | 12/11/2007SE |
| K071967 | Sysmex XE-5000GKZ · Traditional | Sysmex America, Inc. | 11/20/2007SE |
| K071681 | Cytomics FC 500 MPL Flow Cytometer, Model # 626554GKZ · Special | Beckman Coulter, Inc. | 10/04/2007SE |
| K063407 | BC-3200 Auto Hematology AnalyzerGKZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/11/2007SE |
| K071143 | BD Tritest CD3/CD4/CD45, Model 340383GKZ · Special | Bd Biosciences | 06/06/2007SE |
| K071141 | BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402GKZ · Special | Bd Biosciences | 06/06/2007SE |
| K061616 | Coulter LH 780 Hematology AnalyzerGKZ · Abbreviated | Beckman Coulter, Inc. | 10/04/2006SE |
| K062087 | BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962GKZ · Special | Bd Biosciences | 09/14/2006SE |
| K060423 | Cyan DXD, Multitest CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC and FluorospheresGKZ · Traditional | Dakocytomation California, Inc. | 08/15/2006SE |
| K061574 | Coulter LH 750 Hematology Analyzer, Model 6605632GKZ · Traditional | Beckman Coulter, Inc. | 07/21/2006SE |
| K061667 | Cell-Dyn Ruby SystemGKZ · Special | Abbott Laboratories | 07/10/2006SE |
| K061150 | Sysmex Automated Hematology Analyzer, Xt-SeriesGKZ · Traditional | Sysmex America, Inc. | 07/06/2006SE |
| K060375 | BD Multitest 6-COLOR TBNK Reagent with BD Trucount Tubes with Models 337 and 166GKZ · Traditional | Bd Biosciences | 06/06/2006SE |
| K060656 | Sysmex Automated Hematology Analyzer Models XS SeriesGKZ · Traditional | Sysmex America, Inc. | 05/10/2006SE |
| K053497 | Guava EZCD4 SystemGKZ · Traditional | Guava Technologies, Inc. | 04/14/2006SE |
| K053308 | Abx Micros CRP 200, Option ImGKZ · Special | Horiba Abx | 12/29/2005SE |
| K050758 | Chempaq XBC AnalyzerGKZ · Traditional | Chempaq A/S | 12/22/2005SE |
| K052905 | Modification to Coulter LH 750 Hematology AnalyzerGKZ · Special | Beckman Coulter, Inc. | 11/18/2005SE |
| K051459 | Sysmex Model XE-2100DC Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 09/23/2005SE |
| K050421 | MS 4/5 Hematology AnalyzerGKZ · Abbreviated | Melet Schloesing Laboratories USA | 08/31/2005SE |
| K051199 | Ipf (Immature Platelet Fraction) Parameter on the Sysmex Model XE-2100 Automated…GKZ · Traditional | Sysmex America, Inc. | 08/08/2005SE |
| K051122 | Itag MHC Tetramer CMV AssayGKZ · Traditional | Beckman Coulter, Inc. | 08/01/2005SE |
| K050436 | MS 9/5 Hematology AnalyzerGKZ · Abbreviated | Melet Schloesing Laboratories USA | 07/27/2005SE |
| K051215 | Cell-Dyn Sapphire SystemGKZ · Traditional | Abbott Laboratories | 07/21/2005SE |
| K050589 | Ret-He Parameter on the Sysmex Model XE-2100 Automated Hematology AnalyzerGKZ · Traditional | Sysmex America, Inc. | 05/04/2005SE |
| K050719 | Abx Pentra DX 120: Option SPS EvolutionGKZ · Traditional | Horiba Abx | 04/26/2005SE |
| K050057 | Coulter LH 750 Hematology AnalyzerGKZ · Special | Beckman Coulter, Inc. | 02/10/2005SE |
| K043215 | Flowcare PLG CD4 ReagentGKZ · Abbreviated | Beckman Coulter, Inc. | 01/19/2005SE |
| K041882 | Flowcare SystemGKZ · Traditional | Pointcare Technologies, Inc. | 11/23/2004SE |
| K042724 | Modification to Coulter LH 500 Hematology AnalyzerGKZ · Special | Beckman Coulter, Inc. | 10/29/2004SE |
| K042173 | Coulter a T 5DIFF Cap Pierce (CP)GKZ · Abbreviated | Beckman Coulter, Inc. | 10/12/2004SE |
| K042251 | Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKZ · Special | Bayer Healthcare, LLC | 09/17/2004SE |
| K041074 | BD Facscanto with BD Facsanto SoftwareGKZ · Traditional | Bd Biosciences | 09/17/2004SE |
| K040725 | BD Facscanto SystemGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 09/10/2004SE |
| K040026 | BD Facs 7-COLOR Setup BeadsGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 09/10/2004SE |
| K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L)GKZ · Traditional | Sysmex America, Inc. | 03/18/2004SE |
| K032214 | Medonic CA620/530 Hematology AnalyzerGKZ · Traditional | Boule Medical AB | 01/29/2004SE |
| K030263 | Immunicon Celltracks AnalyzerGKZ · Traditional | Immunicon Corp. | 11/24/2003SE |
| K032342 | Coulter LH 750 Hematology AnalyzerGKZ · Abbreviated | Beckman Coulter, Inc. | 09/26/2003SE |
| K032524 | Advia 60 Hematology AnalyzerGKZ · Special | Bayer Healthcare, LLC | 09/08/2003SE |
| K032039 | Immature Granulocyte (Ig) Parameter on the Sysmex Model XE-2100 Automated Hematology…GKZ · Traditional | Sysmex America, Inc. | 09/08/2003SE |
| K032000 | Coulter LH 500 Hematology AnalyzerGKZ · Abbreviated | Beckman Coulter, Inc. | 08/13/2003SE |
| K032013 | Coulter Act 5DIFF Al Hematology AnalyzerGKZ · Special | Beckman Coulter, Inc. | 07/24/2003SE |
| K030828 | Tetracxp System (Software and System Guide)GKZ · Abbreviated | Beckman Coulter, Inc. | 05/21/2003SE |
| K030513 | Cell-Dyn 1800 SystemGKZ · Traditional | Abbott Laboratories | 05/12/2003SE |
| K030606 | Coulter LH 750 Body Fluids ApplicationGKZ · Abbreviated | Beckman Coulter, Inc. | 04/21/2003SE |
| K030291 | Coulter Act 5DIFF Autoloader (Al)GKZ · Abbreviated | Beckman Coulter, Inc. | 04/17/2003SE |
| K030799 | Micros 60GKZ · Special | Abx Diagnostics | 04/08/2003SE |
| K030408 | Cyto-Stat Tetrachrome CD45-FIT/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat…GKZ · Special | Beckman Coulter, Inc. | 03/04/2003SE |
| K030144 | Modification to Pentra 60 and Pentra 60C+GKZ · Special | Abx Diagnostics | 01/31/2003SE |
| K024002 | Pentra 80GKZ · Special | Abx Diagnostics | 01/03/2003SE |
| K022668 | Advia 120 Hematology System Complete Blood Count (CBC) MethodGKZ · Traditional | Bayer Diagnostics Corp. | 10/15/2002SE |
| K022528 | Iq Products Triple-Color Flow Cytometry Reagents, Iq Products CD45-FITC/CD4-PE/CD3-CYQ…GKZ · Traditional | Iq Corp. | 09/11/2002SE |
| K022200 | Pentra 120/PENTRA 120 Retic Options SPS, Model Pentra 120GKZ · Special | Abx Diagnostics | 07/29/2002SE |
| K022161 | Modification to Coulter LH 750 Hematology Analyzer, Model 6605632GKZ · Special | Beckman Coulter, Inc. | 07/29/2002SE |
| K021241 | Sysmex Xt-Series, Model XT-2000I and XT-1800IGKZ · Traditional | Sysmex Corporation of America | 06/25/2002SE |
| K020496 | HPC (Hematopoietic Progenitor Cell) Parameter on the Imi Channel of the Sysmex SE-9500…GKZ · Traditional | Sysmex Corporation of America | 04/12/2002SE |
| K012934 | Cell-Dyn 3200 System with Absolute and Percent ReticulocyteGKZ · Special | Abbott Laboratories | 09/28/2001SE |
| K012904 | Advia 120 Hematology System, Cyanide-Free High DeterminationGKZ · Special | Bayer Diagnostics Corp. | 09/21/2001SE |
| K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632GKZ · Traditional | Beckman Coulter, Inc. | 07/09/2001SE |
| K010953 | Cell-Dyn 4000 Immuno T-Cell (CD3/4/8) AssayGKZ · Traditional | Abbott Laboratories | 06/06/2001SE |
| K010765 | Coulter HMX Analyzer, Model 6605523, Coulter HMX with Autoloader, Model 6605526GKZ · Special | Beckman Coulter, Inc. | 04/13/2001SE |
| K003796 | Advia 120 HematologyGKZ · Traditional | Bayer Corp. | 02/05/2001SE |
| K003677 | Abx Pentra 60C+ Hematology AnalyzerGKZ · Special | Abx Diagnostics | 12/26/2000SE |
| K002646 | Abx Micros CRPGKZ · Traditional | Abx Diagnostics | 10/26/2000SE |
| K000611 | Steller CD61 Assay for Use on the Imagn 2000 Microvolume FluorimeterGKZ · Traditional | Bd Biosciences | 05/18/2000SE |
| K000897 | Calibrite PERCP-CY5.5 Beads and Facscomp SoftwareGKZ · Traditional | Bd Biosciences | 05/05/2000SE |
| K993356 | Coulter Hematology Analyzers with Irf & MRV AnalysesGKZ · Traditional | Coulter Corp. | 04/20/2000SE |
| K992875 | Sysmex XE-2100, Automatated Hematology AnalyzerGKZ · Traditional | Sysmex Corp. | 11/09/1999SE |
| K992511 | Abx Pentra 60 Hematology AnalyzerGKZ · Traditional | Abx Diagnostics | 10/15/1999SE |
| K992444 | Modification of: Cell-Dyn 1200 SystemGKZ · Traditional | Abbott Laboratories | 09/24/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/23/1999SE |
| K991839 | Abx Pentra 120 Retic Automated Hematology AnalyzerGKZ · Traditional | Abx Diagnostics | 08/11/1999SE |
| K991605 | Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System…GKZ · Traditional | Abbott Laboratories | 07/09/1999SE |
| K991539 | Excell 22GKZ · Traditional | Mwi, Inc. | 07/01/1999SE |
| K991142 | Cell-Dyn 1200 SystemGKZ · Abbreviated | Abbott Laboratories | 06/23/1999SE |
| K991454 | Mouse IGG1 Negative ControlsGKZ · Traditional | Dako Corp. | 06/21/1999SE |
| K991402 | Dako Mouse Anti-Human T-Cell, CD3/RPE-CY5, Clone UCHT1 & Dako Mouse Anti-Human T-Cell…GKZ · Traditional | Dako Corp. | 06/21/1999SE |
| K990327 | Reticone System for Epics XL Flow Cytometry SystemsGKZ · Traditional | Coulter Corp. | 04/26/1999SE |
| K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…GKZ · Traditional | Coulter Corp. | 04/13/1999SE |
| K990352 | Coulter Ac T Diff 2 AnalyzerGKZ · Traditional | Coulter Corp. | 04/01/1999SE |
| K990311 | Vega Retic Automated Hematology AnalyzerGKZ · Traditional | Abx Diagnostics | 03/31/1999SE |
| K982167 | Cyto-Stat Trichrome CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | Coulter Corp. | 11/09/1998SE |
| K982166 | Cyto-Stat Trichrome CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent with…GKZ · Traditional | Coulter Corp. | 11/05/1998SE |
| K983562 | Mascot MD Hematology Analyzer/ Model MD 700GKZ · Special | Cdc Technologies, Inc. | 11/03/1998SE |
| K982172 | Cyto-Stat CD3-FITC/CD56-RDI Monoclonal Antibody Reagent with Cyto-Stat/Coulter Clone…GKZ · Traditional | Coulter Corp. | 09/24/1998SE |
| K982802 | Bayer Advia 60 Hematology System (in Vitro Diagnostic System)GKZ · Traditional | Bayer Corp. | 09/22/1998SE |
| K981568 | Mascot MD Hematology Analyzer, Model MD 800GKZ · Traditional | Cdc Technologies, Inc. | 08/21/1998SE |
| K980635 | Dako Mouse Anti-Human B-Cell, CD19/RPE-CY5, Clone HD37GKZ · Traditional | Dako Corp. | 07/22/1998SE |
| K982231 | StatusflowGKZ · Special | R&D Systems, Inc. | 07/20/1998SE |
| K981342 | Abbott Cell-Dyn 4000 Immunopit (CD61) AssayGKZ · Traditional | Abbott Laboratories | 06/29/1998SE |
| K980858 | Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 05/22/1998SE |
| K980614 | Abbott Cell-Dyn 3000 Series Hematology SystemsGKZ · Traditional | Abbott Laboratories | 04/24/1998SE |
| K974360 | Multitest CD3/CD8/CD45/CD4GKZ · Traditional | Becton Dickinson Immunocytometry Systems | 03/11/1998SE |
| K973483 | Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 02/17/1998SE |
| K971205 | Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count TubesGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 12/01/1997SE |
| K971110 | Tritest Reagent CD3 FITC/CD16+CD56 PE/CD45 Percp;With Trucount Absolute Count TubesGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 11/25/1997SE |
| K970326 | Tritest Reagent CD3 FITC/CD8 PE/CD45 Percp;With Trucount Absolute Count TubesGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 11/21/1997SE |
| K965053 | Tritest Reagent CD3 FITC/CD4 PE/CD45 Percp; Trucount Absolute Count TubesGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 11/21/1997SE |
| K973634 | Coulter Ac.T Diff AnalyzerGKZ · Traditional | Coulter Corp. | 10/29/1997SE |
| K970742 | Tritest CD3 FITC/CD19 PE/CD45 Percp Reagent with Trucount Absolute Count TubesGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 10/22/1997SE |
| K972354 | Abbott Cell-Dyn 3200 SystemGKZ · Traditional | Abbott Laboratories | 09/16/1997SE |
| K971736 | Sysmex Immature Reticulocyte Fraction (Irf) ParameterGKZ · Traditional | Sysmex Corp. | 08/26/1997SE |
| K970836 | Trucount Absolute Count Tubes/Counting Control BeadsGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 08/26/1997SE |
| K971152 | Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf)GKZ · Traditional | Abbott Laboratories | 08/12/1997SE |
| K951459 | Ortho-Mune Okt 4A (CD4) - Monoclonal Antibody (Murine) Fitc ConjugateGKZ · Traditional | Ortho Diagnostic Systems, Inc. | 07/14/1997SE |
| K964974 | Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/RpeGKZ · Traditional | Dako Corp. | 06/24/1997SE |
| K965232 | Caltag Cal-LyseGKZ · Traditional | Caltag Laboratories, Inc. | 05/14/1997SE |
| K964988 | Coulter Ac.T Series AnalyzerGKZ · Traditional | Coulter Corp. | 03/06/1997SE |
| K960072 | Spirit Hematology System Model Le, CP, & AxGKZ · Traditional | Biochem Immunosystems (U.S.), Inc. | 03/06/1997SE |
| K951632 | Ortho-Mune Ok-Combo Control IGG2A-FITC/IGG2A-PE Monoclonal Antibody (Murine)GKZ · Traditional | Ortho Diagnostic Systems, Inc. | 03/06/1997SE |
| K964754 | Ortho-Mune Okb (CD19)- Monoclonal Antibody (Murine) Phycoerythrine ConjugateGKZ · Traditional | Ortho Diagnostic Systems, Inc. | 01/22/1997SE |
| K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…GKZ · Traditional | Coulter Corp. | 01/22/1997SE |
| K964856 | CD3 FITC/CD19 R-PE/CD45 Tri-Color Monoclonal Antibody CombinationGKZ · Traditional | Caltag Laboratories, Inc. | 01/17/1997SE |
| K962768 | Cyto-Stat Trichrome CD45-FITC/CD4-RDI/CD3-PC5 Monoclonal Anitbody Reagent W/Isotypic…GKZ · Traditional | Coulter Corp. | 01/06/1997SE |
| K962305 | Cyto-Stat Trichrome CD45-FITC/CD8-RD1/CD3-PC5 Monoclonal Antibody Reagent Iwth Isotypic…GKZ · Traditional | Coulter Corp. | 01/06/1997SE |
| K964618 | Cyto-Stat Trichrome CD8-FITC/CD4-RDI/CD3-PC5 Monoclonal Antibody Reagent with Cyto-Stat…GKZ · Traditional | Coulter Corp. | 12/23/1996SE |
| K963963 | Multiset Software for Automated Flow Cytometric Data AnalysisGKZ · Traditional | Becton Dickinson Immunocytometry Systems | 12/12/1996SE |
| K963954 | CD 19 R-Pe, CD19 Tri-Color Monoclonal AntibodyGKZ · Traditional | Caltag Laboratories, Inc. | 11/25/1996SE |
| K962633 | Vega Hematology AnalyzerGKZ · Traditional | Abx, Inc. | 11/04/1996SE |
| K961439 | Abbott Cell-Dyn 4000 SystemGKZ · Traditional | Abbott Diagnostics | 10/18/1996SE |
| K955715 | Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification)GKZ · Traditional | Abbott Laboratories | 10/08/1996SE |
| K954594 | Reticulocyte Method, RBC IndicesGKZ · Traditional | Bayer Corp. | 08/23/1996SE |
| K961278 | Coulter STKS Analyzer with CD4 & CD8 Lymphocyte AnalysisGKZ · Traditional | Coulter Corp. | 07/22/1996SE |
| K961701 | Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) RpeGKZ · Traditional | Dako Corp. | 07/16/1996SE |
| K961610 | R & D Systems' Whole Blood Flow Control, (R & D - WBFC)GKZ · Traditional | R&D Systems, Inc. | 07/01/1996SE |
| K961435 | Mouse Anti-Human CD2, T-Cell/Fitc and Mouse Anti-Human CD19, B-Cell/RpeGKZ · Traditional | Dako Corp. | 06/14/1996SE |
| K960531 | Mouse Anti-Human CD3, T-Cell/Fitc & CD19, B-Cell/RpeGKZ · Traditional | Dako Corp. | 06/14/1996SE |
| K961623 | Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsGKZ · Traditional | Becton Dickinson Monoclonal Center | 06/07/1996SE |
| K942525 | Medicount Deka Hematology AnalyzerGKZ · Traditional | Cea America Corp. | 06/05/1996SE |
| K955673 | Cell Dyn 3000 Multi-Parameter Automated Hematology Analyzer (Modification)GKZ · Traditional | Abbott Laboratories | 05/20/1996SE |
| K960887 | Mouse Anti-Human CD4, T-Cell, Helper/Inducer/Fitc & CD8, T-Cell, Suppressor/Cytotoxic/RpeGKZ · Traditional | Dako Corp. | 05/17/1996SE |
| K960827 | QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)GKZ · Traditional | Becton Dickinson Diagnostic Instrument Systems | 05/17/1996SE |
| K953116 | White Iris Leukocyte Differential AnalyzerGKZ · Traditional | Intl. Remote Imaging Systems | 05/13/1996SE |
| K951100 | Ortho-Mune Ok-Combo CD3-FITC/CD19-PE (OKT3/OKB19A Monolclonal Antibody (Murine)GKZ · Traditional | Ortho Diagnostic Systems, Inc. | 05/13/1996SE |
| K950625 | Ortho-Mune Ok-Combo CD40FITC/CD8-PE (OKT4A/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | Ortho Diagnostic Systems, Inc. | 05/13/1996SE |
| K950568 | Ortho-Mune Ok-Combo CD3-FITC/CD4-PE (OKT2/OKT4A) Monoclonal Antibody (Murine)GKZ · Traditional | Ortho Diagnostic Systems, Inc. | 05/13/1996SE |
| K950482 | Ortho-Mune Ok-Comvo CD3-FITC/CD8-PE (Okt 3/OKT8) Monoclonal Antibody (Murine)GKZ · Traditional | Ortho Diagnostic Systems, Inc. | 05/10/1996SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0489-2026 Class II | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number:…Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when… | Abbott Laboratories | 09/18/2025Open, 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… | Beckman Coulter Inc. | 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… | Beckman Coulter Inc. | 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… | Beckman Coulter Inc. | 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… | Beckman Coulter Inc. | 08/13/2025Open, Classified |
| Z-2238-2025 Class II | BD Trucount Controls, 30 Test - REF: 340335Control kits contain incorrect standard deviation (SD) values for the low and high control beads which… | Becton, Dickinson and Company, BD Bio… | 07/08/2025Open, Classified |
| Z-2237-2025 Class II | BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVDControl kits contain incorrect standard deviation (SD) values for the low and high control beads which… | Becton, Dickinson and Company, BD Bio… | 07/08/2025Open, Classified |
| Z-2079-2025 Class II | REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for…Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect… | Becton, Dickinson and Company, BD Bio… | 06/03/2025Open, Classified |
| Z-2078-2025 Class II | REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in…Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect… | Becton, Dickinson and Company, BD Bio… | 06/03/2025Open, Classified |
| Z-1656-2025 Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84…When expired reagents are scanned or manually entered, the system will change the expiration date to current… | Abbott Laboratories | 03/18/2025Open, Classified |
| Z-1655-2025 Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13…When expired reagents are scanned or manually entered, the system will change the expiration date to current… | Abbott Laboratories | 03/18/2025Open, Classified |
| Z-1654-2025 Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10…When expired reagents are scanned or manually entered, the system will change the expiration date to current… | Abbott Laboratories | 03/18/2025Open, Classified |
| Z-1653-2025 Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03…When expired reagents are scanned or manually entered, the system will change the expiration date to current… | Abbott Laboratories | 03/18/2025Open, Classified |
| Z-1652-2025 Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01…When expired reagents are scanned or manually entered, the system will change the expiration date to current… | Abbott Laboratories | 03/18/2025Open, Classified |
| Z-2681-2024 Class II | Alinity hq Analyzer, REF: 09P68-011)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately… | Abbott Laboratories | 06/14/2024Open, Classified |
| Z-2173-2024 Class II | Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample…One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination… | Sight Diagnostics Ltd | 05/13/2024Open, Classified |
| Z-0604-2024 Class II | Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire…The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry… | Abbott Laboratories | 10/19/2023Open, Classified |
| Z-0173-2023 Class II | BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use…Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or… | Becton, Dickinson and Company, BD Biosciences | 10/03/2022Open, Classified |
| Z-0172-2023 Class II | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes…Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or… | Becton, Dickinson and Company, BD Biosciences | 10/03/2022Open, Classified |
| Z-0171-2023 Class II | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes…Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or… | Becton, Dickinson and Company, BD Biosciences | 10/03/2022Open, Classified |
| Z-1469-2022 Class II | Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly… | Sight Diagnostics Ltd | 06/14/2022Open, Classified |
| Z-0963-2022 Class II | The Sight OLO device is a computer vision based platform for blood analysis. The…In instances where custom reference ranges were configured on the device post installation, a possibility to… | Sight Diagnostics Ltd | 01/20/2022Open, Classified |
| Z-2517-2021 Class II | Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1…Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and… | Sight Diagnostics Ltd | 03/17/2021Terminated |
| Z-1405-2021 Class II | ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1404-2021 Class II | ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1403-2021 Class II | ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1402-2021 Class II | ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1401-2021 Class II | ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1400-2021 Class II | ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1399-2021 Class II | ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1398-2021 Class II | ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1397-2021 Class II | ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1396-2021 Class II | ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1395-2021 Class II | ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1394-2021 Class II | ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1393-2021 Class II | ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1392-2021 Class II | ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1391-2021 Class II | ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1390-2021 Class II | ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1389-2021 Class II | ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1388-2021 Class II | ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1387-2021 Class II | ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1386-2021 Class II | ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology…Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Siemens Healthcare Diagnostics, Inc. | 03/05/2021Open, Classified |
| Z-1001-2020 Class II | Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product…A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk… | Clinical Diagnostic Solutions, Inc. | 01/02/2020Terminated |
| 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… | Beckman Coulter, Inc. | 10/07/2019Terminated |
| Z-0173-2020 Class II | Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument…The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer… | Abbott Laboratories | 05/09/2019Terminated |
| Z-1074-2019 Class II | CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology…There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters… | Abbott Laboratories | 02/20/2019Terminated |
| 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.… | Beckman Coulter Inc. | 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.… | Beckman Coulter Inc. | 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.… | Beckman Coulter Inc. | 07/30/2018Terminated |