Home / Brands / Abbott Laboratories
Abbott Laboratories Recalls
156 recalls on record · June 27, 2012 to December 24, 2025 · Drugs, Food & Beverage, Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 13, 2020Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal
Hazard: Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
May 13, 2020Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal ins
Hazard: Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
April 15, 2020Medical DevicesFDA
Abbott Laboratories recalls "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use i
Hazard: Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
April 15, 2020Medical DevicesFDA
Abbott Laboratories, Inc recalls ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemi
Hazard: Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed.
October 30, 2019Medical DevicesFDA
Abbott Laboratories recalls Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm
Hazard: The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
October 16, 2019Food & BeverageFDA
Abbott Laboratories recalls Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
Hazard: Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.
October 2, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Hazard: The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.
July 31, 2019Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the d
Hazard: Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
July 31, 2019Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSys
Hazard: Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
July 31, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasm
Hazard: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
July 31, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum
Hazard: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
July 31, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay
Hazard: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
July 31, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sa
Hazard: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
July 31, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human seru
Hazard: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
July 31, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum
Hazard: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
July 31, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum
Hazard: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
July 31, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum
Hazard: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
July 31, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3
Hazard: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
May 22, 2019Medical DevicesFDA
Abbott Laboratories recalls Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed qualit
Hazard: Devices were delivered without the required dry ice.
May 22, 2019Medical DevicesFDA
Abbott Laboratories recalls Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed qualit
Hazard: Devices were delivered without the required dry ice.
May 22, 2019Medical DevicesFDA
Abbott Laboratories recalls ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinit
Hazard: Devices were delivered without the required dry ice.
May 22, 2019Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Cont
Hazard: Devices were delivered without the required dry ice.
May 22, 2019Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls
Hazard: Devices were delivered without the required dry ice.
May 22, 2019Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the AR
Hazard: Devices were delivered without the required dry ice.
May 22, 2019Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHI
Hazard: Devices were delivered without the required dry ice.
May 22, 2019Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i
Hazard: Devices were delivered without the required dry ice.
May 22, 2019Medical DevicesFDA
Abbott Laboratories recalls ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCH
Hazard: Devices were delivered without the required dry ice.
May 15, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Techn
Hazard: There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
April 17, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for I
Hazard: There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
April 17, 2019Medical DevicesFDA
Abbott Laboratories, Inc recalls Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In
Hazard: There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.