Abbott Laboratories, Inc
Irving, TX
This page shows every FDA and USDA recall linked to Abbott Laboratories, Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
78
Total Recalls
2000
First Recall
2022
Most Recent
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479
The Alinity s System...
Feb 3, 2022
· Device
Active
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor...
Jul 12, 2021
· Device
Active
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform autom...
May 1, 2019
· Device
Terminated
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31
The Magnesium assay is used for the quantitation of magnesi...
Jan 2, 2019
· Device
Terminated
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Sep 7, 2018
· Device
Terminated
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03.
Product Usage:
The ARCHITECT cSystems ICT (Integrated Chi...
Aug 28, 2018
· Device
Terminated
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Jul 18, 2018
· Device
Terminated
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Jul 18, 2018
· Device
Terminated
Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is inten...
Jul 17, 2018
· Device
Terminated
Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is inten...
Jul 17, 2018
· Device
Terminated
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is inte...
Jul 17, 2018
· Device
Terminated
The,K -ASSAY HP assay is intended for the quantitative
determination of human haptoglobin by immunoturbidimet...
May 16, 2018
· Device
Terminated
C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human
serum or plasma. Antibodi...
May 16, 2018
· Device
Terminated
Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of
immunoglobulin M in hum...
May 16, 2018
· Device
Terminated
Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of
apolipoprotein B in hum...
May 16, 2018
· Device
Terminated
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of
immunoglobulin G in hum...
May 16, 2018
· Device
Terminated
C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human
serum or plasma. Antigen...
May 16, 2018
· Device
Terminated
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of
apolipoprotein A1 in h...
May 16, 2018
· Device
Terminated
Transferrin is an in vitro diagnostic assay for the quantitative determination of
transferrin in human serum...
May 16, 2018
· Device
Terminated
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of
immunoglobulin A in hum...
May 16, 2018
· Device
Terminated
ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry syste...
Jan 18, 2018
· Device
Terminated
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system....
Jan 18, 2018
· Device
Terminated
ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system....
Jan 18, 2018
· Device
Terminated
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Sep 29, 2017
· Device
Completed
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clin...
Sep 29, 2017
· Device
Completed
ARCHITECT i2000SR System
The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHIT...
Sep 9, 2015
· Device
Terminated
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abb...
Jan 15, 2015
· Device
Terminated
Lipase Reagent, 7D80.
Used to measure lipase in human serum on the Architect system.
Oct 28, 2014
· Device
Terminated
Clinical Chemistry Phosphorus Reagent
The Phosphorus assay is used for the quantitation of phosphorus in hum...
Oct 17, 2013
· Device
Terminated
Clinical Chemistry Phenobarbital, list number 1E08
Apr 15, 2013
· Device
Terminated
ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List N...
Mar 25, 2013
· Device
Terminated
Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in...
Nov 16, 2011
· Device
Terminated
Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31.
Used for the quantitation of alkaline...
Sep 26, 2011
· Device
Terminated
ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott Park, IL
P...
Sep 23, 2010
· Device
Terminated
ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-2047...
Apr 9, 2010
· Device
Terminated
ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit.
ARCHITECT Sy...
Nov 9, 2009
· Device
Terminated
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (...
Sep 18, 2009
· Device
Terminated
ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco...
Feb 5, 2009
· Device
Terminated
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected softwa...
Sep 11, 2008
· Device
Terminated
Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064
May 24, 2008
· Device
Terminated
Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL
Jan 25, 2008
· Device
Terminated
Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Par...
Nov 24, 2007
· Device
Terminated
ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2....
Nov 7, 2007
· Device
Terminated
ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v...
Nov 7, 2007
· Device
Terminated
ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (...
Jul 3, 2007
· Device
Terminated
ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v2.11, v2.12, v2.20,...
Jun 19, 2007
· Device
Terminated
ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number 3M74-01; v2.10, v2.11, v2.12, v2.20...
Jun 19, 2007
· Device
Terminated
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01; Affected software: v2.10, v2...
Jun 19, 2007
· Device
Terminated
ARCHITECT c16000 Processing Module, for in vitro diagnostics; List Number 3L77-01; Affected software: v2.10, v...
Jun 19, 2007
· Device
Terminated
ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; manufactured by Abbot Labor...
May 9, 2007
· Device
Terminated