Abbott Laboratories
Medical device manufacturer in Abbott Park, IL.
889510(k) clearances
28PMA approvals
218recalls
Device types
- FRN Pump, Infusion 67
- FPA Set, Administration, Intravascular 30
- GKZ Counter, Differential Cell 24
- KNT Tubes, Gastrointestinal (And Accessories) 23
- JHI Visual, Pregnancy Hcg, Prescription Use 15
- CIG Diazo Colorimetry, Bilirubin 15
- JJE Analyzer, Chemistry (Photometric… 13
- CDP Radioimmunoassay, Total Triiodothyronine 13
- LGD Enzyme Linked Immunoabsorbent Assay… 12
- NBW System, Test, Blood Glucose, Over The Counter 12
- FPB Filter, Infusion Line 11
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 10
- LJC Enzyme Linked Immunoabsorbent Assay… 10
- GTZ Antisera, All Groups, Streptococcus Spp. 9
- DQO Catheter, Intravascular, Diagnostic 9
- FOZ Catheter, Intravascular, Therapeutic… 8
- CEC Radioimmunoassay, Free Thyroxine 8
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 8
- DKZ Enzyme Immunoassay, Amphetamine 8
- CGX Alkaline Picrate, Colorimetry, Creatinine 8
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K252424 | Anti-HCV NextMZO · Traditional | 04/28/2026SE |
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | 08/30/2024SE |
| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…DHA · Traditional | 05/19/2023SE |
| K223602 | Traumatic brain injury (TBI) testQAT · Traditional | 03/02/2023SE |
| K220949 | Architect CMV IgGLFZ · Traditional | 10/27/2022SE |
| K210596 | ARCHITECT Toxo IgGLGD · Traditional | 05/19/2022SE |
| K213486 | GLP systems TrackJGS · Traditional | 03/10/2022SE |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity SystemQAT · Traditional | 01/08/2021SE |
| K190294 | CELL-DYN Emerald 22 AL SystemGKZ · Special | 03/15/2019SE |
| K181748 | MagnesiumJGJ · Traditional | 09/12/2018SE |
| K173294 | MagnesiumJGJ · Traditional | 05/18/2018SE |
| K173122 | Abbott Architect Free T4CEC · Special | 10/27/2017SE |
| K170320 | Alinity c ICT Sample DiluentCGZ · Traditional | 10/24/2017SE |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHA · Traditional | 10/23/2017SE |
| K170316 | Alinity C Glucose Reagent Kit, Alinity C SystemCFR · Traditional | 10/19/2017SE |
| K163342 | i-STAT Hematocrit test with i-STAT Alinity SystemJPI · Traditional | 08/22/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | 02/15/2017SE |
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT…MRG · Traditional | 08/12/2016SE |
| K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP…LIP · Traditional | 06/15/2016SE |
| K152442 | Freestyle Freedom Blood Glucose Monitoring SytemNBW · Special | 12/17/2015SE |
| K152155 | ARCHITECT 2nd Generation TestosteroneCDZ · Traditional | 12/17/2015SE |
| K151566 | Abbott ARCHITECT Total T4 CalibratorsJIT · Traditional | 07/10/2015SE |
| K150531 | FreeStyle Freedom Lite Blood Glucose Monitoring SystemNBW · Special | 06/05/2015SE |
| K150332 | FreeStyle Lite Blood Glucose Monitoring SystemNBW · Special | 06/05/2015SE |
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c ControlsPDJ · Traditional | 05/22/2015SE |
| K150510 | Total BilirubinCIG · Traditional | 04/02/2015SE |
| K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsPDJ · Traditional | 02/28/2014SE |
| K123089 | Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001NBW · Traditional | 04/05/2013SE |
| K121985 | Architect Total BilirubinCIG · Traditional | 02/01/2013SE |
| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | 01/14/2013SE |
| K121003 | Abbott Plex-Id Flu AssayOCC · Traditional | 12/21/2012SE |
| K123379 | Abbott Architect Free T4CEC · Special | 11/27/2012SE |
| K120009 | Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)CDZ · Traditional | 09/11/2012SE |
| K113704 | Architect Havab-GLOL · Traditional | 06/28/2012SE |
| K121314 | Architect B12CDD · Traditional | 05/17/2012SE |
| K113719 | Safety Screw ConnectorKNT · Traditional | 04/20/2012SE |
| K111874 | Freestyle Insulinx Blood Glucose Monitoring SystemsLFR · Traditional | 02/16/2012SE |
| K110381 | Cell-Dyn Emerald 22 SystemGKZ · Traditional | 12/22/2011SE |
| K103627 | Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine CalibratorsKLT · Traditional | 10/14/2011SE |
| K110579 | Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 ControlsCDD · Traditional | 10/06/2011SE |
| K111023 | Abbott Architect LH CalibratorsJIT · Traditional | 06/10/2011SE |
| K102568 | Uric Acid Model 3P39KNK · Traditional | 05/06/2011SE |
| K110909 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WIRE-WORKHORSE-190CM…NTE · Special | 04/29/2011SE |
| K102699 | Architect Igentamicin Reagents; Architect Igentamicin CalibratorsLCD · Traditional | 04/01/2011SE |
| K103403 | Multiconstituent CalibratorJIX · Traditional | 02/04/2011SE |
| K092740 | Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls…CGN · Traditional | 03/05/2010SE |
| K093318 | Accelerator ApsCEM · Traditional | 02/19/2010SE |
| K090358 | Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35…LEG · Traditional | 08/06/2009SE |
| K083809 | CreatinineCGX · Special | 04/07/2009SE |
| K081495 | Cell-Dyn Emerald SystemGKZ · Traditional | 02/04/2009SE |
| K081231 | Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33…DLZ · Traditional | 09/26/2008SE |
| K080696 | Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and…DIP · Traditional | 09/11/2008SE |
| K081549 | RX Accunet LP Embolic Protection SystemNTE · Traditional | 08/19/2008SE |
| K071525 | Activated Aspartate AminotransferaseCIT · Traditional | 03/19/2008SE |
| K072824 | Fox SV Pta CatheterLIT · Special | 10/23/2007SE |
| K063329 | Abbott Architect Havab-MLOL · Abbreviated | 04/16/2007SE |
| K062855 | CalciumCJY · Traditional | 11/22/2006SE |
| K062843 | Fox SV Pta CatheterLIT · Special | 10/17/2006SE |
| K061667 | Cell-Dyn Ruby SystemGKZ · Special | 07/10/2006SE |
| K061193 | CreatinineCGX · Traditional | 06/23/2006SE |
| K060875 | Abbott Axsym Troponin-I AdvMMI · Traditional | 06/14/2006SE |
| K061249 | Axsym Digoxin IIIKXT · Special | 06/02/2006SE |
| K060383 | GlucoseCFR · Traditional | 05/05/2006SE |
| K060295 | Carbon DioxideKHS · Traditional | 05/04/2006SE |
| K060574 | Total BilirubinCIG · Traditional | 05/03/2006SE |
| K053330 | Architect B12 CalibratorsJIT · Special | 12/16/2005SE |
| K051962 | Ultra HDLLBS · Traditional | 08/25/2005SE |
| K051327 | Abbott Axsym B12CDD · Traditional | 08/03/2005SE |
| K051215 | Cell-Dyn Sapphire SystemGKZ · Traditional | 07/21/2005SE |
| K051125 | Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677FZP · Special | 06/08/2005SE |
| K051213 | Precision Xtra Plus or Optium Plus, Blood Glucose Test StripsNBW · Special | 05/27/2005SE |
| K050534 | Xpert Self-Expanding Transhepatic Biliary Stent SystemFGE · Special | 05/20/2005SESU |
| K050103 | Xceed Nitinol Self-Expanding Transhepatic Biliary Stent SystemFGE · Special | 02/16/2005SE |
| K041962 | Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589…FGE · Traditional | 10/01/2004SE |
| K041811 | Abbott Axsym Troponin-I AdvMMI · Traditional | 09/10/2004SE |
| K041687 | Abbott Immunoassay/Clinical Chemistry Single Analyte Quality Control Materials (Assayed)…JJX · Abbreviated | 08/18/2004SE |
| K041550 | Hospira Phoenix Infusion System with Hospira Mednet SoftwareFRN · Traditional | 06/30/2004SE |
| K040954 | Fox Plus Pta CatheterLIT · Special | 05/11/2004SE |
| K040761 | Axsym CyclosporineMKW · Traditional | 04/30/2004SE |
| K040814 | Modification to Precision Xtra Advanced Diabetes Management SystemNBW · Special | 04/15/2004SE |
| K040667 | Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008…FGE · Special | 04/07/2004SESU |
| K040628 | Precision Link Diabetes Data Management SystemNBW · Special | 03/25/2004SE |
| K033909 | Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemFGE · Traditional | 02/17/2004SESU |
| K040114 | Abbott Data Port PC, Model 12181FRN · Special | 01/29/2004SE |
| K033845 | Precision Xceed Diabetes Monitoring SystemNBW · Special | 01/08/2004SE |
| K033537 | Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006…FGE · Special | 12/10/2003SESU |
| K033576 | Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible…FPA · Special | 12/04/2003SE |
| K032458 | Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx…JIT · Abbreviated | 10/06/2003SE |
| K030899 | C-Reactive Protein (CRP)DCN · Traditional | 07/02/2003SE |
| K030513 | Cell-Dyn 1800 SystemGKZ · Traditional | 05/12/2003SE |
| K031185 | Abbott Plum A+ Infusion Pump with a Hpl/Rs Plug-And-Play ModuleFRN · Traditional | 04/30/2003SE |
| K023256 | Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood Glucose Test…NBW · Traditional | 04/23/2003SE |
| K030002 | Lifeshield Primary IV Set Conv. Pin. Clave; LF LC 5000 Plumset-Dual W/Conv Pin & Cap…FPA · Special | 01/27/2003SE |
| K024067 | Rheumatoid Factor (RF)DHR · Traditional | 01/15/2003SE |
| K024126 | Clear or Braided Contrast Media Injection Line or Without Rotator, Cath Lab KitDQO · Special | 01/14/2003SE |
| K024239 | Chemo Dispensing Pin, Model 12495LHI · Special | 01/13/2003SE |
| K024084 | Abbott Plum A+ Infusion Pump, Model 12391FRN · Special | 12/31/2002SE |
| K023807 | Modification to AlkpCJE · Special | 12/26/2002SE |
| K023397 | Abbott Architect FolateCGN · Traditional | 12/16/2002SE |
| K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose TestingLFR · Traditional | 10/28/2002SE |
| K023062 | Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain ManagementFRN · Special | 09/30/2002SE |
| K022339 | Total BilirubinCIG · Traditional | 09/13/2002SE |
| K022182 | Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood…NBW · Traditional | 09/09/2002SE |
| K022180 | Direct BilirubinCIG · Traditional | 09/06/2002SE |
| K021960 | Precision Point of Care Blood Glucose Test Strip with True Measure TechnologyLFR · Traditional | 08/16/2002SE |
| K022203 | Abbott Lifecare Pca 3 Infuser, Model 12384MEA · Special | 08/01/2002SE |
| K021874 | Abbott Q2 Plus S02/CONTINUOUS Cardiac Output Computer, List Number 56711DXG · Traditional | 07/12/2002SE |
| K021350 | Abbott Plum A+3 Multichannel Infusion Pump, Model 12348FRN · Special | 05/14/2002SE |
| K013100 | PropoxypheneJXN · Traditional | 03/20/2002SE |
| K013001 | MethadoneDJR · Traditional | 03/20/2002SE |
| K012996 | BarbituratesDIS · Traditional | 03/20/2002SE |
| K013314 | OpiatesDJG · Traditional | 03/13/2002SE |
| K013247 | CannabinoidsLDJ · Traditional | 03/13/2002SE |
| K013143 | BenzodiazepinesJXM · Traditional | 03/13/2002SE |
| K013096 | PhencyclidineLCM · Traditional | 03/13/2002SE |
| K013004 | CocaineDIO · Traditional | 03/13/2002SE |
| K012998 | Amphetamine/MethamphetamineLAF · Traditional | 03/13/2002SE |
| K012975 | Sof-Tact Diabetes Management Sysyem; Sof-Tact Blood Glucose Test Strip; Precision…NBW · Traditional | 02/28/2002SE |
| K013538 | EthanolDML · Traditional | 12/14/2001SE |
| K012934 | Cell-Dyn 3200 System with Absolute and Percent ReticulocyteGKZ · Special | 09/28/2001SE |
| K010553 | Precision Xtra Blood Glucose Test Strip with Truemeasure TechnologyNBW · Traditional | 06/18/2001SE |
| K010953 | Cell-Dyn 4000 Immuno T-Cell (CD3/4/8) AssayGKZ · Traditional | 06/06/2001SE |
| K011442 | Abbott Plum A+Infusion Pump, Model 11971FRN · Special | 06/05/2001SE |
| K011217 | Clear or Braided Contrast Media Injection Line with or Without Rotator, Cath Lab KitDQO · Special | 05/16/2001SE |
| K011096 | Abbott Acclaim Encore, Model 12237FRN · Special | 05/01/2001SE |
| K010924 | Modification to Plum XL Infusion PumpFRN · Special | 04/06/2001SE |
| K002717 | Sterile Piston SyringeFMF · Traditional | 01/08/2001SE |
| K001993 | Sof-Tact Diabetes Management System; Sof-Tact Glucose Test Strip; Precision Control…LFR · Traditional | 11/13/2000SE |
| K000886 | Spirol Epidural CatheterBSO · Traditional | 10/05/2000SE |
| K002006 | Lifeshield Additive Piercing PinFPA · Traditional | 08/10/2000SE |
| K001616 | Modification to Syringe Prefilled with 0.9% Sodium ChlorideFOZ · Special | 07/27/2000SE |
| K002126 | Abbott Acclaim Encore Standard Tubing PumpFRN · Special | 07/20/2000SE |
| K992085 | Abbott Imx Glycated Hemoglobin IILCP · Traditional | 05/25/2000SE |
| K000821 | Abbott Gemstar I.V. Infusion Pump - 7 Therapy Configuration, 6 Therapy Configuration, 1…FRN · Special | 03/24/2000SE |
| K994039 | Abbott Gemstar I.V. Infusion PUMP-7 Therapy Configuration, Abbott Gemstar I.V. Infusion…FRN · Special | 12/22/1999SE |
| K992710 | Abbott Architech Glycated Hemoglobin MastercheckJJY · Traditional | 11/24/1999SE |
| K991483 | Abbott Architect Glycated HemoglobinLCP · Traditional | 11/01/1999SE |
| K992858 | Abbott Axsym HomocysteineLPS · Traditional | 10/25/1999SE |
| K993083 | Alcyon 300I (with Ise Module) AnalyzerCEM · Special | 10/05/1999SE |
| K992444 | Modification of: Cell-Dyn 1200 SystemGKZ · Traditional | 09/24/1999SE |
| K991605 | Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System…GKZ · Traditional | 07/09/1999SE |
| K991142 | Cell-Dyn 1200 SystemGKZ · Abbreviated | 06/23/1999SE |
| K991372 | CRPDCN · Traditional | 06/01/1999SE |
| K991175 | Modification to Alcyon Direct BilirubinCIG · Traditional | 05/28/1999SE |
| K991501 | Acclaim Infusion PumpFRN · Special | 05/13/1999SE |
| K990774 | Abbott Architect CeaDHX · Traditional | 05/11/1999SE |
| K990035 | RFDHR · Traditional | 03/08/1999SE |
| K990373 | Fact Plus One Step Pregnancy TestLCX · Special | 02/22/1999SE |
| K983070 | CKCGS · Traditional | 02/16/1999SE |
| K984301 | Abbott Architect FolateCGN · Traditional | 02/05/1999SE |
| K984108 | Abbott Architect B12LIG · Traditional | 02/03/1999SE |
| K983289 | Apolipoprotein A1DER · Traditional | 01/29/1999SE |
| K983774 | UalbJIR · Traditional | 01/28/1999SE |
| K983281 | ApobDFC · Traditional | 01/26/1999SE |
| K982159 | Abbott Plum A+ Infusion PumpFRN · Traditional | 01/12/1999SE |
| K983759 | Abbott Architect FerritinDBF · Traditional | 12/07/1998SE |
| K983424 | Abbott Archeitect Total B-HcgDHA · Traditional | 12/01/1998SE |
| K983440 | Abbott Architect Total T4KLI · Traditional | 11/25/1998SE |
| K983838 | Abbott Lifecare Standard Tubing Infusion PumpFRN · Traditional | 11/20/1998SE |
| K983442 | Abbott Architect TSHJLW · Traditional | 11/20/1998SE |
| K983439 | Abbott Architect Free T3CDP · Traditional | 11/20/1998SE |
| K983434 | Abbott Architect Total T3CDP · Traditional | 11/20/1998SE |
| K983417 | Abbott Architect Free T4CEC · Traditional | 11/20/1998SE |
| K983212 | Abbott Architect TestosteroneCDZ · Traditional | 11/18/1998SE |
| K982362 | Abbott Testpack Plus H. PyloriLYR · Traditional | 11/18/1998SE |
| K983848 | Abbott Axsym MyoglobinDDR · Traditional | 11/16/1998SE |
| K983441 | C3CZW · Traditional | 11/04/1998SE |
| K983359 | IgaCZP · Traditional | 11/04/1998SE |
| K983356 | C4DBI · Traditional | 11/04/1998SE |
| K983221 | IggDEW · Traditional | 11/04/1998SE |
| K983167 | TRFDDG · Traditional | 11/04/1998SE |
| K983132 | IgmDFT · Traditional | 11/04/1998SE |
| K981791 | MGJGJ · Traditional | 10/23/1998SE |
| K981295 | UproJGQ · Traditional | 10/01/1998SE |
| K983131 | AstCIT · Traditional | 09/28/1998SE |
| K983134 | NbilMQM · Traditional | 09/23/1998SE |
| K981682 | UproJGQ · Traditional | 09/21/1998SE |
| K983133 | TbilCIG · Traditional | 09/16/1998SE |
| K981653 | AmyJFJ · Traditional | 08/28/1998SE |
| K981303 | Direct LDLMRR · Traditional | 08/03/1998SE |
| K981224 | Direct HDLLBS · Traditional | 08/03/1998SE |
| K982041 | UibcJMO · Traditional | 07/30/1998SE |
| K981918 | UreaCDQ · Traditional | 07/28/1998SE |
| K981943 | DbilCIG · Traditional | 07/22/1998SE |
| K981920 | AmmJIF · Traditional | 07/22/1998SE |
| K981814 | AlbpCJW · Traditional | 07/22/1998SE |
| K981799 | CreaCGX · Traditional | 07/22/1998SE |
| K981654 | TibcJMO · Traditional | 07/22/1998SE |
| K981706 | Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, Upro Cal, and Ise…JIX · Traditional | 07/09/1998SE |
| K981843 | AstCIT · Traditional | 06/29/1998SE |
| K981652 | CholCHH · Traditional | 06/29/1998SE |
| K981342 | Abbott Cell-Dyn 4000 Immunopit (CD61) AssayGKZ · Traditional | 06/29/1998SE |
| K981476 | CholCHH · Traditional | 06/25/1998SE |
| K981806 | AlkpCJE · Traditional | 06/22/1998SE |
| K981467 | AmmJIF · Traditional | 06/22/1998SE |
| K981766 | Uric AcidCDO · Traditional | 06/19/1998SE |
| K981759 | PhosCEO · Traditional | 06/16/1998SE |
| K981578 | CaCJY · Traditional | 06/16/1998SE |
| K981758 | AlbgCIX · Traditional | 06/12/1998SE |
| K981118 | PhosCEO · Traditional | 06/12/1998SE |
| K981580 | HDLLBS · Traditional | 06/11/1998SE |
| K981840 | CO2KHS · Traditional | 06/08/1998SE |
| K981581 | IronCFM · Traditional | 06/08/1998SE |
| K981216 | AmyJFJ · Traditional | 06/08/1998SE |
| K981240 | Creatinine (Crea)CGX · Traditional | 05/29/1998SE |
| K981468 | AlbgCIX · Traditional | 05/27/1998SE |
| K981279 | TibcJMO · Traditional | 05/20/1998SE |
| K981245 | Alkaline Phosphatase (Alkp)CJE · Traditional | 05/20/1998SE |
| K981338 | LD-1JGF · Traditional | 05/18/1998SE |
| K981189 | Uric AcidCDO · Traditional | 05/07/1998SE |
| K981185 | GluCFR · Traditional | 05/07/1998SE |
| K981336 | TbilCIG · Traditional | 05/01/1998SE |
| K981241 | IronJIY · Traditional | 05/01/1998SE |
| K981218 | Creatine Kinase (CK)CGS · Traditional | 05/01/1998SE |
| K981192 | MGJGJ · Traditional | 05/01/1998SE |
| K981060 | Abbott Axsym 3RD Generation TSH AssayJLW · Traditional | 04/29/1998SE |
| K981222 | Direct Bilirubin (Dbil)CIG · Traditional | 04/24/1998SE |
| K980614 | Abbott Cell-Dyn 3000 Series Hematology SystemsGKZ · Traditional | 04/24/1998SE |
| K981225 | Aspartate Aminotransferase (Ast)CIT · Traditional | 04/23/1998SE |
| K981221 | Aspartate Aminotransferase Activated ( Ast Activated)CIT · Traditional | 04/23/1998SE |
| K980367 | Aeroset SystemCGZ · Traditional | 04/01/1998SE |
| K974778 | Abbott Gemstar IV Infusion PumpFRN · Traditional | 03/17/1998SE |
| K971522 | Abbott Testpack Plus Strep a with on Board Controls (Obc) IIGTZ · Traditional | 03/03/1998SE |
| K974779 | Abbott Alcyon(Tm) 300 (Without Ise Module) and 300I (with Ise Module) AnalyzerJJE · Traditional | 02/13/1998SE |
| K974651 | Abbott Axsym SystemJJE · Traditional | 02/12/1998SE |
| K974103 | Abbott Axsym Troponin-IMMI · Traditional | 11/25/1997SE |
| K964407 | Imx Ca 15-3MOI · Traditional | 11/10/1997SE |
| K962554 | Flexiflo Low-Profile Balloon Gastrostomy TubeKNT · Traditional | 11/07/1997SE |
| K964020 | Axsym Ca 125LTK · Traditional | 11/04/1997SE |
| K972354 | Abbott Cell-Dyn 3200 SystemGKZ · Traditional | 09/16/1997SE |
| K963926 | Axsym Ca 15-3MOI · Traditional | 09/15/1997SE |
| K971152 | Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf)GKZ · Traditional | 08/12/1997SE |
| K972232 | Abbott Axsym FolateCGN · Traditional | 06/24/1997SE |
| K965186 | Axsym B12CDD · Traditional | 03/24/1997SE |
| K954301 | Abbott CMV Total Antibody Eia (Modification)LFZ · Traditional | 03/24/1997SE |
| K961661 | Oximetrix 4 Computer SystemDXG · Traditional | 03/04/1997SE |
| K970527 | Abbott HCG Serum ControlsJJX · Traditional | 03/03/1997SE |
| K963351 | Lifeshield Blunt CannulaFMI · Traditional | 02/26/1997SE |
| K965116 | Abbott Testpack Plus HCG Combo with ObcJHI · Traditional | 02/20/1997SE |
| K961552 | CVP Polyurethane CatheterFOZ · Traditional | 02/10/1997SE |
| K970082 | Abbott Advisor One-Step Pregnancy TestLCX · Traditional | 01/24/1997SE |
| K963833 | Imx Free Triiodothyronine (Free T3)CDP · Traditional | 10/30/1996SE |
| K963827 | Axsym Free Triiodothyronine (Free T3)CDP · Traditional | 10/30/1996SE |
| K955715 | Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification)GKZ · Traditional | 10/08/1996SE |
| K963113 | Flexiflo Polyg Gastostomy TubeKNT · Traditional | 10/02/1996SE |
| K954045 | Axsym Rubella Igg Antibody AssayLFX · Traditional | 09/24/1996SE |
| K953943 | Axsym CMV Igg Antibody AssayLFZ · Traditional | 09/20/1996SE |
| K962467 | RV Pacing LeadLDF · Traditional | 09/17/1996SE |
| K963158 | Abbott Axsym Digitoxin (Modify)LFM · Traditional | 09/10/1996SE |
| K954576 | Axsym Toxo IgmLGD · Traditional | 08/23/1996SE |
| K954575 | Axsym Toxo Igg Antibody AssayLGD · Traditional | 08/16/1996SE |
| K951541 | Imx Rubella IggLFX · Traditional | 07/16/1996SE |
| K953805 | 0.9% Sodium Chloride Diluent in Plastic SyringeFOZ · Traditional | 06/28/1996SE |
| K936054 | Imx Select ChlamydiaLJC · Traditional | 05/30/1996SE |
| K960466 | IVEX-2 Extension Set with Y-Injection Site (Modification)LHI · Traditional | 05/29/1996SE |
| K954283 | Energized Container System (Modification)FPA · Traditional | 05/29/1996SE |
| K955673 | Cell Dyn 3000 Multi-Parameter Automated Hematology Analyzer (Modification)GKZ · Traditional | 05/20/1996SE |
| K954318 | Abbott Axsym Rubella Igm Antibody AssayLFX · Traditional | 05/14/1996SE |
| K955851 | Axsym Vancomycin IILEH · Traditional | 05/09/1996SE |
| K955410 | Snapdose DeviceFPA · Traditional | 05/06/1996SE |
| K935833 | LCX Neisseria Gonorrhoeae AssayLSL · Traditional | 05/06/1996SE |
| K955422 | Axsym N-AcetylprocainamideLAN · Traditional | 04/24/1996SE |
| K955444 | Abbott Axsm Procainamide AssayLAR · Traditional | 04/02/1996SE |
| K955025 | Axsym ProgesteroneJLS · Traditional | 03/07/1996SE |
| K952819 | Abbott Testpack Plus Strep a with on Board Controls (Obc)GTZ · Traditional | 01/26/1996SE |
| K952799 | Abbott XL3M Infusion PumpFRN · Traditional | 01/18/1996SE |
| K954420 | Axsym DigitoxinLFM · Traditional | 12/29/1995SE |
| K953731 | Pancretec Provider Apm Infusion Pump (Modification)FRN · Traditional | 12/13/1995SE |
| K934622 | LCX Chlamydia Trachomatis AssayMKZ · Traditional | 12/08/1995SE |
| K953761 | Axsym Tricyclic AntidepressantsLFH · Traditional | 11/22/1995SE |
| K953499 | Axsym MethadoneDJR · Traditional | 11/13/1995SE |
| K953534 | Axsym Phencyclidine IILCM · Traditional | 10/26/1995SE |
| K953584 | Lifeshield Luer Activated Valve Male Adapter PlugFPA · Traditional | 10/24/1995SE |
| K951496 | Cell-Dyn 3500 Multi-Parameter Automated Hematology AnalyzerGKZ · Traditional | 10/19/1995SE |
| K953660 | Plum XL Infusion Pump (Modification)FRN · Traditional | 10/17/1995SE |
| K953115 | Axsym Amphetamine/Methamphetamine IIDKZ · Traditional | 10/06/1995SE |
| K954029 | Testpack Plus HCG UrineJHI · Traditional | 10/05/1995SE |
| K953221 | Abbott Vision Hemoglobin (Modification)KHG · Traditional | 09/29/1995SE |
| K953765 | Axsym Rea EthanolDML · Traditional | 09/27/1995SE |
| K953840 | Axsym Phenytoin IILGR · Traditional | 09/25/1995SE |
| K953718 | Axsym Digoxin IIKXT · Traditional | 09/25/1995SE |
| K933825 | Adi SystemFRN · Traditional | 09/19/1995SE |
| K953094 | Axsym AcetaminophenLDP · Traditional | 08/24/1995SE |
| K953016 | Axsym Theophylline IILGS · Traditional | 08/24/1995SE |
| K945571 | Abbott Test Pack Strep a TestGTZ · Traditional | 08/14/1995SE |
| K951290 | Axsym SalicylateDKJ · Traditional | 08/08/1995SE |
| K951289 | Axsym Cocaine MetaboliteDIO · Traditional | 08/02/1995SE |
| K951636 | Imx Toxo IggLGD · Traditional | 08/01/1995SE |
| K952079 | Imx DigoxinKXT · Traditional | 07/19/1995SE |
| K952148 | Axsym Ultrasensitive HTSH IIJLW · Traditional | 06/29/1995SE |
| K945566 | Abbott Project I, SpectrumJJE · Traditional | 06/09/1995SE |
| K936285 | Abbott Vision Glycated HB, ModificationLCP · Traditional | 06/09/1995SE |
PMA approvals
- P210003 ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit · 08/10/2022 · 13 supplements
- P120008 Abbott Architect Afp Assay · 11/28/2012 · 32 supplements
- P110029 Architect Hbsag Qualitative, Qualitative Confirmatory, Confirmatory Manual Diluent, Calibrators, and Controls · 04/12/2012 · 51 supplements
- P080023 Architect Core Reagent Kit, Architect Core Calibrator and Architect Core Controls · 04/10/2009 · 46 supplements
- P050020 Freestyle Navigator Continuous Glucose Monitor · 03/12/2008 · 30 supplements
- P060035 Architect Core-M Reagent Kit/Calibrators/Controls · 11/06/2007 · 43 supplements
- P060012 Axsym Core 2.0 and Axsym Core 2.0 Controls · 09/08/2006 · 10 supplements
- P060007 Architect Hbsag Reagent Kit, Calibrators, Controls, Confirmatory Reagent Kit, Confirmatory Manual Diluent · 09/07/2006 · 27 supplements
- P060009 Axsym Core-M 2.0 and Axsym Core-M 2.0 Controls · 08/25/2006 · 7 supplements
- P060003 Axsym, Ausab · 08/07/2006 · 12 supplements
- P050042 Architect Anti-Hcv Assay; Architect Anti-Hcv Calibrator; Architect Anti-Hcv Control · 06/07/2006 · 47 supplements
- P050051 Abbott Architect Ausab · 06/01/2006 · 60 supplements
- P050049 Axsym Hbsag, Hbsag Confirmatory, and Axsym Hbsag Controls · 06/01/2006 · 11 supplements
- P980007 Axsym Free Psa · 02/05/2004 · 55 supplements
- P970027 Abbott Axsym Antibody to HCV · 02/05/2004 · 18 supplements
- P970007 Imx Tacrolimus II Assay · 08/26/1997 · 4 supplements
- P920006 Immunocytochemical Assay to Detect Progesterone · 09/26/1995 · 0 supplements
- P910007 Axsym Total Psa & Architect Total Psa · 09/25/1991 · 67 supplements
- P900013 Abbott Pgr-Eia Monoclonal · 09/06/1990 · 2 supplements
- P890025 TD Cyclosporine and Metabolites Serum Assay · 12/14/1989 · 13 supplements
- P850029 Abbott Er-Eia Monoclonal Diag. Kit · 10/17/1988 · 2 supplements
- P880026 Abbott Er-Ica Monoclonal · 09/30/1988 · 0 supplements
- P850062 Abbott Anti-Delta Diagnostic Kit (Ria) · 07/01/1986 · 3 supplements
- P780005 Abbott Afp · 06/25/1984 · 1 supplement
- P820060 Abbott Afp-Eia Diagnostic Kit for Cancer · 06/21/1983 · 28 supplements
- P790025 Abbott Hbe Diagnostic Kit · 07/15/1980 · 6 supplements
- P790019 Havab-M Diagnostic Kit · 06/10/1980 · 19 supplements
- P780012 Havab · 01/19/1979 · 14 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-0961-2026 Class II | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay… | 11/13/2025Open, Classified |
| 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… | 09/18/2025Open, 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… | 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… | 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… | 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… | 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… | 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… | 06/14/2024Open, Classified |
| Z-1476-2024 Class II | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of… | 02/21/2024Open, Classified |
| Z-0682-2024 Class II | ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The…The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry… | 10/19/2023Open, Classified |
| Z-0681-2024 Class II | Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully…The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry… | 10/19/2023Open, Classified |
| Z-0680-2024 Class II | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully…The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry… | 10/19/2023Open, 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… | 10/19/2023Open, Classified |
| Z-0613-2024 Class II | Alinity ci-series System Control Module, REF: 03R70-01There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and… | 05/30/2023Open, Classified |
| Z-0958-2023 Class III | Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT…Reaction vessels may contain a potential contaminant that could affect their optical performance. | 11/24/2022Open, Classified |
| Z-1660-2022 Class II | ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the… | 07/26/2022Open, Classified |
| Z-1456-2022 Class II | REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL…There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using… | 06/09/2022Open, Classified |
| Z-1455-2022 Class II | REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL…There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using… | 06/09/2022Open, Classified |
| Z-1454-2022 Class II | REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL…There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using… | 06/09/2022Open, Classified |
| Z-0891-2022 Class II | ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin…This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is… | 03/08/2022Open, Classified |
| Z-0749-2022 Class II | Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479…Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer… | 02/03/2022Open, Classified |
| Z-0272-2022 Class II | ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF…Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues… | 09/29/2021Open, Classified |
| Z-0271-2022 Class II | ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74…Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues… | 09/29/2021Open, Classified |
| Z-2472-2021 Class II | Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for…Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1)… | 07/26/2021Open, Classified |
| Z-2276-2021 Class II | Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic…A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray… | 07/12/2021Open, Classified |
| Z-2187-2021 Class II | REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE…There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater… | 06/10/2021Open, Classified |
| Z-2186-2021 Class II | REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE…There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater… | 06/10/2021Open, Classified |
| Z-2185-2021 Class II | REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE…There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater… | 06/10/2021Open, Classified |
| Z-2184-2021 Class II | REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c…There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater… | 06/10/2021Open, Classified |
| Z-2251-2020 Class II | Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR…In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module… | 04/02/2020Terminated |
| Z-1895-2020 Class III | ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and…Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents… | 04/01/2020Terminated |
| Z-1894-2020 Class III | ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and…Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents… | 04/01/2020Terminated |
| Z-1893-2020 Class III | ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and…Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents… | 04/01/2020Terminated |
| Z-2079-2019 Class III | ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation…Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP… | 05/24/2019Terminated |
| Z-2078-2019 Class III | ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the…Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP… | 05/24/2019Terminated |
| Z-1688-2020 Class II | "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH…Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer… | 05/22/2019Terminated |
| 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… | 05/09/2019Terminated |
| Z-1671-2020 Class II | ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is…Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the… | 05/01/2019Terminated |
| Z-1363-2019 Class III | Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1362-2019 Class III | Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1361-2019 Class III | ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1360-2019 Class III | ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1359-2019 Class III | ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1358-2019 Class III | ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1357-2019 Class III | ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1356-2019 Class III | ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1355-2019 Class III | ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| 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… | 02/20/2019Terminated |
| Z-0971-2019 Class II | ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the…Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine… | 01/02/2019Terminated |
| Z-2755-2019 Class II | APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser…The firm identified customer sites where modules which the safety pacemaker label is missing. Information… | 09/07/2018Terminated |
| Z-1296-2019 Class II | Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT…There is a potential to generate falsely elevated serum or plasma chloride results when using the product. | 08/28/2018Terminated |
| Z-1076-2019 Class II | Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.The product has a stability issue which may lead to an error code indicating "Unable to calculate result… | 07/18/2018Terminated |
| Z-1075-2019 Class II | Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.The product has a stability issue which may lead to an error code indicating "Unable to calculate result… | 07/18/2018Terminated |
| Z-1104-2019 Class II | Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott…There is a potential to generate incorrect results on the instrument if particular error codes are not… | 07/17/2018Terminated |
| Z-1103-2019 Class II | Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott…There is a potential to generate incorrect results on the instrument if particular error codes are not… | 07/17/2018Terminated |
| Z-1102-2019 Class II | Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott…There is a potential to generate incorrect results on the instrument if particular error codes are not… | 07/17/2018Terminated |
| Z-2522-2018 Class II | CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics…Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model… | 06/14/2018Terminated |
| Z-1995-2019 Class II | Transferrin is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1994-2019 Class II | Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1993-2019 Class II | The,K -ASSAY HP assay is intended for the quantitative determination of human…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1992-2019 Class II | C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1991-2019 Class II | Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1990-2019 Class II | Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1989-2019 Class II | Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1988-2019 Class II | Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-1987-2019 Class II | C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | 05/16/2018Terminated |
| Z-0923-2018 Class II | ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT…There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached… | 12/08/2017Terminated |
| Z-0922-2018 Class II | ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT…There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached… | 12/08/2017Terminated |
| Z-0921-2018 Class II | ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT…There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached… | 12/08/2017Terminated |
| Z-0166-2018 Class II | Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due… | 09/29/2017Completed |
| Z-0165-2018 Class II | ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000…The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due… | 09/29/2017Completed |
| Z-2613-2017 Class II | ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle…Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may… | 04/18/2017Terminated |
| Z-1438-2017 Class II | CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a…The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely… | 02/13/2017Terminated |
| Z-0379-2017 Class II | ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the…Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic… | 10/11/2016Terminated |
| Z-1865-2016 Class II | The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in…Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results… | 03/24/2016Terminated |
| Z-1522-2016 Class II | CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN…Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out… | 03/24/2016Terminated |
| Z-0163-2016 Class II | ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic…Incorrect tubing. | 09/09/2015Terminated |
| Z-2202-2015 Class II | ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem…The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to… | 06/11/2015Terminated |
| Z-1725-2015 Class II | Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect…The product is leaking from the cap and crystallization was noted as present around the cap. | 05/11/2015Terminated |
| Z-0011-2018 Class II | ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is…There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached… | 01/15/2015Terminated |
| Z-1932-2015 Class II | ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium…ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on… | 07/22/2014Terminated |
| Z-0135-2015 Class II | HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6…HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot.… | 04/30/2014Terminated |
| Z-0131-2015 Class II | Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.Package inserts have incorrect SmartWash parameters for Triglyceride. | 04/07/2014Terminated |
| Z-1672-2014 Class II | ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic…Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to… | 02/12/2014Terminated |
| Z-1671-2014 Class II | ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A…Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to… | 02/12/2014Terminated |
| Z-0020-2014 Class II | Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation…Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates… | 08/12/2013Terminated |
| Z-0987-2013 Class II | ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative…Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative… | 12/18/2012Terminated |
| Z-0698-2013 Class II | Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27…The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed… | 12/12/2012Terminated |
| Z-1118-2013 Class II | Clinical Chemistry Phenobarbital, list number 1E08Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to… | 11/16/2012Terminated |
| Z-1904-2012 Class II | ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100…The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott… | 05/30/2012Terminated |
| Z-1509-2012 | ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro…The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to… | 04/11/2012Terminated |
| Z-0162-2012 | ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle…The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with… | 10/07/2011Terminated |
| Z-0189-2012 | Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the…The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate… | 10/03/2011Terminated |
| Z-3278-2011 | Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the…The reagent has the potential to be contaminated with mold, the Cladosporium fungal species. | 08/26/2011Terminated |
| Z-3031-2011 | ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for…C-Peptide lots 03610K000 and 01711A000 have the potential to generate falsely elevated results with certain… | 07/11/2011Terminated |
| Z-2413-2011 | ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for…The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false… | 04/20/2011Terminated |
| Z-2020-2011 | CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2019-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. Abbott Diagnostics…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2018-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2017-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2016-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2015-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-2014-2011 | CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS…The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient… | 03/15/2011Terminated |
| Z-1094-2011 | Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List…There is the potential for the instrument to not power up due to the flash memory issue. This will result in… | 10/15/2010Terminated |
| Z-1668-2011 | Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is…The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume… | 09/30/2010Terminated |
| Z-0629-2011 | ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay…The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in… | 09/13/2010Terminated |
| Z-0068-2011 | Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle…There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the… | 09/07/2010Terminated |
| Z-2172-2010 | Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL)…The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors. | 05/27/2010Terminated |
| Z-2398-2010 | Clinical Chemistry Phosphorus assayProduct may give inaccurate results and aspiration errors with reagent configuration, including results… | 05/04/2010Terminated |
| Z-2171-2010 | IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus…IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors. | 04/30/2010Terminated |
| Z-2353-2010 | CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara…Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous… | 04/16/2010Terminated |
| Z-2352-2010 | CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA.…Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous… | 04/16/2010Terminated |
| Z-2351-2010 | CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa…Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous… | 04/16/2010Terminated |
| Z-2350-2010 | CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa…Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous… | 04/16/2010Terminated |
| Z-2421-2010 | CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor)…Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail… | 04/05/2010Terminated |
| Z-1733-2011 | Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The…Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings… | 03/23/2010Terminated |
| Z-1434-2012 | Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG…Observed particulate matter in some reagent cartridges. | 03/10/2010Terminated |
| Z-1623-2011 | CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated…A component used in assembly is out of specification, resulting in failure to retract, eject specimens… | 12/29/2009Terminated |
| Z-1698-2011 | The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are…The use of the device assemblies has been extended to a 6 month useful life. | 11/30/2009Terminated |
| Z-1316-2010 | ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number…ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch… | 09/11/2009Terminated |
| Z-0132-2010 | ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism…Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the… | 07/17/2009Terminated |
| Z-0065-2010 | CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott…Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated… | 07/16/2009Terminated |
| Z-1425-2012 | Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative…Abbott Laboratories has issued a recall on the Clinical Chemistry Total Bilirubin due to an under-recovery… | 07/09/2009Terminated |
| Z-1630-2010 | CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa…Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in… | 06/08/2009Terminated |
| Z-1629-2010 | CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by…Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in… | 06/08/2009Terminated |
| Z-1628-2010 | CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology…Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in… | 06/08/2009Terminated |
| Z-2325-2009 | ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i…There continues to be an elevated level of complaint activity for calibration error code 1227, when using… | 04/24/2009Terminated |
| Z-2752-2011 | Abbott CELL-DYN 1700 Analyzer, CELL-DYN 1700 CS (Closed Sample).Manufactured by Abbott…Expanded Recall to include these additional products: FIRE HAZARD-- Some power supply modules may have… | 03/27/2009Terminated |
| Z-1902-2011 | Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (Sample Loader). Manufactured…Expanded Recall to include these additional products: FIRE HAZARD-- Some power supply modules may have… | 03/27/2009Terminated |
| Z-1703-2011 | Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample…FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and… | 03/27/2009Terminated |
| Z-1702-2011 | Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample…FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and… | 03/27/2009Terminated |
| Z-1701-2011 | Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL…FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and… | 03/27/2009Terminated |
| Z-1392-2009 | ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the…Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test… | 02/26/2009Terminated |
| Z-2222-2009 | Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM…The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low… | 02/20/2009Terminated |
| Z-2317-2009 | AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories…Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were… | 02/18/2009Terminated |
| Z-1398-2009 | Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number…Burn Risk-- when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may… | 02/12/2009Terminated |
| Z-1051-2009 | AxSYM Troponin-I ADV Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1050-2009 | AxSYM Myoglobin Reagent Pack, Abbott Laboratories, Abbott Park, IL 60064; AxSYM…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1049-2009 | AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1048-2009 | AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1047-2009 | AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1046-2009 | AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | 01/19/2009Terminated |
| Z-1069-2009 | Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire…Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe… | 12/10/2008Terminated |
| Z-1064-2009 | CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a…Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count. | 11/17/2008Terminated |
| Z-2221-2009 | ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by…When an ARCHITECT c16000 System is connected to an ACCELERATOR APS System, the software on the ACCELERATOR… | 10/27/2008Terminated |
| Z-2482-2010 | ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott…During manufacturing, two components of the ARCHITECT i1000SR were reversed which could potentially cause… | 10/21/2008Terminated |
| Z-0580-2009 | ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is…The field action was initiated after an investigation for the Total Bilirubin reagents (List Number 8G62 and… | 09/12/2008Terminated |
| Z-0951-2009 | ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01…ACCELERATOR APS Centrifuge Module being recalled due to potential for micro-cracks to form over time in the… | 09/09/2008Terminated |
| Z-0216-2009 | Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL…The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do… | 09/05/2008Terminated |
| Z-0306-2009 | CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi-…Exposed wire resulted in minor electrical shock and burn to the service technician | 08/25/2008Terminated |
| Z-1447-2012 | ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate…This letter is to inform you that some samples may generate A-AST results of less than (<) 5 U/L or results… | 06/30/2008Terminated |
| Z-2305-2008 | Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with…Product was incorrectly labeled as "Top-Fill Enteral Nutrition Bag" instead of "Flexiflo Quantum Pump Set." | 06/27/2008Terminated |
| Z-2239-2008 | ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and…When running the Automated Dilution Protocol with the assay files "CMV IgG" or "Toxo IgG" on the ARCHITECT… | 06/16/2008Terminated |
| Z-2175-2008 | AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20…An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes… | 06/02/2008Terminated |
| Z-2231-2008 | ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and…Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting… | 05/23/2008Terminated |
| Z-0950-2009 | Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03…An incorrect Magnesium calibrator 2 value (CAL 2) was provided for Clinical Chemistry Iron/Magnesium… | 04/24/2008Terminated |
| Z-2139-2008 | CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface…Table in LIS Specification depicting the association between Record ID and Numerical Result Label is… | 04/11/2008Terminated |
| Z-1570-2008 | Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and…Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4… | 02/27/2008Terminated |
| Z-1569-2008 | Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and…Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4… | 02/27/2008Terminated |
| Z-2059-2008 | ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation…An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of… | 02/15/2008Terminated |
| Z-1462-2008 | AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La…Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after… | 01/21/2008Terminated |
| Z-1165-2008 | CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology…Count may be out of specification--Hemoglobin background count may be out of specification (high) after… | 01/15/2008Terminated |
| Z-1103-2008 | White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire…Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas… | 12/19/2007Terminated |
| Z-0551-2008 | Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories…Sample/Patient Mis-identification: Two issues identified related to the ACCELERATOR Decision Manager (ADM)… | 10/25/2007Terminated |
| Z-1109-2008 | Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00…Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or… | 10/12/2007Terminated |
| Z-0257-2008 | Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott…Sample problems; Five issues identified related to software utilized by the ACCELERATOR APS System… | 10/10/2007Terminated |
| Z-0127-2008 | Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for…Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components… | 10/01/2007Terminated |
| Z-1166-2008 | Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL…Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all… | 09/26/2007Terminated |
| Z-0299-2008 | ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version…The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the… | 09/18/2007Terminated |
| Z-0147-2008 | ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01…Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT… | 09/05/2007Terminated |
| Z-0146-2008 | ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01…Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT… | 09/05/2007Terminated |
| Z-0288-2008 | Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number…Incorrect Calibrator values: changes in a raw material used in the Bilirubin Calibrator value assignment… | 08/10/2007Terminated |
| Z-0301-2008 | Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number…Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or… | 07/25/2007Terminated |
| Z-1222-2007 | ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL…The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8… | 07/06/2007Terminated |
| Z-1233-2007 | MULTIGENT Acetaminophen, List Number 2K99-20Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a… | 06/01/2007Terminated |
| Z-1232-2007 | Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a… | 06/01/2007Terminated |
| Z-1171-2007 | Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and…Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin… | 05/16/2007Terminated |
| Z-1170-2007 | CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software…Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin… | 05/16/2007Terminated |
| Z-1041-2007 | ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by…Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to… | 05/15/2007Terminated |
| Z-1200-2007 | Abbott CELL-DYN 3700 Hematology AnalyzerThe product failed electrostatic discharge testing, which could result in product failure. | 05/11/2007Terminated |
| Z-1199-2007 | Abbott CELL-DYN 3500 Hematology AnalyzerThe product failed electrostatic discharge testing, which could result in product failure. | 05/11/2007Terminated |
| Z-1198-2007 | Abbott CELL-DYN 3000 Hematology AnalyzerThe product failed electrostatic discharge testing, which could result in product failure. | 05/11/2007Terminated |
| Z-0953-2007 | ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number 3L77-01…One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline… | 04/30/2007Terminated |
| Z-0952-2007 | ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01…One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline… | 04/30/2007Terminated |
| Z-0951-2007 | ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number 3M74-01…One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline… | 04/30/2007Terminated |
| Z-0950-2007 | ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10…One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline… | 04/30/2007Terminated |
| Z-1040-2007 | AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1039-2007 | AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1038-2007 | AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1037-2007 | AxSYM CORE 2.0 Reagent Pack; list 08B88; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1036-2007 | AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1035-2007 | AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1034-2007 | AxSYM Anti-HCV Reagent Pack; list 05C36; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1032-2007 | AxSYM Rubella IgM Reagent Pack; list 04B46; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1031-2007 | AxSYM Toxo IgM Reagent Pack; list 04B25; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1030-2007 | AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1029-2007 | AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1028-2007 | AxSYM AUSAB Reagent Pack; list 03C74; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1027-2007 | AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |
| Z-1026-2007 | AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | 04/23/2007Terminated |