Atlas FDA

Abbott Laboratories, Inc

67 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch Abbott Laboratories, Inc

RecordFirmDate
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinic recall (Z-0921-2018)Abbott Laboratories, Inc2018-01-18
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinic recall (Z-0922-2018)Abbott Laboratories, Inc2018-01-18
ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clin recall (Z-0923-2018)Abbott Laboratories, Inc2018-01-18
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system. recall (Z-0131-2015)Abbott Laboratories, Inc2014-10-28
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of recall (Z-0020-2014)Abbott Laboratories, Inc2013-10-17
Clinical Chemistry Phenobarbital, list number 1E08 recall (Z-1118-2013)Abbott Laboratories, Inc2013-04-15
ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confir recall (Z-0987-2013)Abbott Laboratories, Inc2013-03-25
ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransfe recall (Z-1447-2012)Abbott Laboratories Inc.2012-04-23
Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 5 recall (Z-1434-2012)Abbott Laboratories Inc.2012-04-18
Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative analysi recall (Z-1425-2012)Abbott Laboratories Inc.2012-04-16
Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation recall (Z-0189-2012)Abbott Laboratories, Inc2011-11-16
Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quant recall (Z-3278-2011)Abbott Laboratories, Inc2011-09-26
ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratori recall (Z-2482-2010)Abbott Laboratories, Inc2010-09-23
Clinical Chemistry Phosphorus assay recall (Z-2398-2010)Abbott Laboratories Inc.2010-09-10
ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7- recall (Z-1316-2010)Abbott Laboratories, Inc2010-04-09
ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism groundin recall (Z-0132-2010)Abbott Laboratories, Inc2009-11-09
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by In recall (Z-2221-2009)Abbott Laboratories, Inc2009-09-18
Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lo recall (Z-0950-2009)Abbott Laboratories Inc.2009-02-06
ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; man recall (Z-0951-2009)Abbott Laboratories, Inc2009-02-05
ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is intende recall (Z-0580-2009)Abbott Laboratories Inc.2009-01-12
ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of recall (Z-2059-2008)Abbott Laboratories Inc.2008-09-16
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06- recall (Z-2231-2008)Abbott Laboratories, Inc2008-09-11
Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 6006 recall (Z-1166-2008)Abbott Laboratories, Inc2008-05-24
Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expire recall (Z-1109-2008)Abbott Laboratories Inc.2008-03-19
Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbo recall (Z-0551-2008)Abbott Laboratories, Inc2008-01-25
Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Labo recall (Z-0257-2008)Abbott Laboratories, Inc2007-11-24
ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected recall (Z-0146-2008)Abbott Laboratories, Inc2007-11-07
ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affecte recall (Z-0147-2008)Abbott Laboratories, Inc2007-11-07
Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30 recall (Z-1232-2007)Abbott Laboratories Inc.2007-09-18
MULTIGENT Acetaminophen, List Number 2K99-20 recall (Z-1233-2007)Abbott Laboratories Inc.2007-09-18
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by In recall (Z-1041-2007)Abbott Laboratories, Inc2007-07-03
ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v recall (Z-0950-2007)Abbott Laboratories, Inc2007-06-19
ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number 3M74-01; v2.10, recall (Z-0951-2007)Abbott Laboratories, Inc2007-06-19
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01; Affected recall (Z-0952-2007)Abbott Laboratories, Inc2007-06-19
ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number 3L77-01; Affecte recall (Z-0953-2007)Abbott Laboratories, Inc2007-06-19
ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; manufac recall (Z-0790-2007)Abbott Laboratories, Inc2007-05-09
ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; manufa recall (Z-0791-2007)Abbott Laboratories, Inc2007-05-09
ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test ki recall (Z-0792-2007)Abbott Laboratories, Inc2007-05-09
Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20 recall (Z-0722-2007)Abbott Laboratories Inc.2007-04-05
ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Tempera recall (Z-0415-2007)Abbott Laboratories, Inc2007-02-07
ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temper recall (Z-0416-2007)Abbott Laboratories, Inc2007-02-07
Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Divisio recall (Z-0454-2007)Abbott Laboratories Inc.2007-01-09
ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by recall (Z-0398-06)Abbott Laboratories, Inc2006-01-18
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00. recall (Z-0008-06)Abbott Laboratories, Inc2005-10-06
ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clini recall (Z-0010-06)Abbott Laboratories, Inc2005-10-06
B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, recall (Z-0435-05)Abbott Laboratories, Inc2005-01-26
AEROSET Analyzer, Systems Operation Manual. recall (Z-0016-05)Abbott Laboratories, Inc2004-10-09
ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporati recall (Z-1341-04)Abbott Laboratories, Inc2004-08-13
AEROSET System Software version 1.02ER000 recall (Z-0091-04)Abbott Laboratories, Inc2004-07-20
ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas recall (Z-0172-04)Abbott Laboratories, Inc2004-07-20
AxSYM Analyzer, Small Heater Block Clamp, manufactured by Abbott Laboratories, Irving, Tex recall (Z-0173-04)Abbott Laboratories, Inc2004-07-20
ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Proce recall (Z-0818-04)Abbott Laboratories, Inc2004-07-20
AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Divi recall (Z-0846-04)Abbott Laboratories, Inc2004-07-20
The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving recall (Z-0274-04)Abbott Laboratories, Inc2003-12-25
The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irv recall (Z-0262-04)Abbott Laboratories, Inc2003-12-24
The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irv recall (Z-0263-04)Abbott Laboratories, Inc2003-12-24
Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irv recall (Z-1142-03)Abbott Laboratories, Inc2003-08-21
ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irv recall (Z-1133-03)Abbott Laboratories, Inc2003-08-13
Aeroset Analyzer, item 9D05-01 recall (Z-0843-03)Abbott Laboratories, Inc2003-05-20
AEROSET Analyzer recall (Z-0844-03)Abbott Laboratories, Inc2003-05-20
ARCHITECT i System External Waste Pump recall (Z-0795-03)Abbott Laboratories, Inc2003-05-09
AEROSET System External Waste Pump recall (Z-0796-03)Abbott Laboratories, Inc2003-05-09
AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-0 recall (Z-0788-03)Abbott Laboratories, Inc2003-05-01
AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog nu recall (Z-0725-03)Abbott Laboratories, Inc2003-04-16
AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalo recall (Z-0721-03)Abbott Laboratories, Inc2003-04-15
AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03 recall (Z-0421-03)Abbott Laboratories, Inc2003-01-11
Precision PCx Test Strips Part Number: 98757-12 recall (Z-0403-03)Abbott Laboratories, Inc.2002-12-31

Track Abbott Laboratories, Inc automatically

Every clearance here is in the API, with alerts when new ones post.