Abbott Laboratories, Inc

Complete recall history across all FDA and CPSC categories — 31 total recalls

Abbott Laboratories, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (31)

FDA medical device enforcement actions by Abbott Laboratories, Inc

Date Product Reason Class
Feb 3, 2022 Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)003807... Software error associated with the immunoassay analyzer wash cycle which is ... Class II
Jul 12, 2021 Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vit... A design defect (hardware and software) allows liquid waste pressure to build... Class II
May 1, 2019 ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry Sy... Mixer blade may separate from mixer due to the screw and nut failure and deta... Class II
Jan 2, 2019 ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is u... Abbott internal testing has identified that the Magnesium urine application d... Class II
Sep 7, 2018 APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Clas... The firm identified customer sites where modules which the safety pacemaker l... Class II
Aug 28, 2018 Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The AR... There is a potential to generate falsely elevated serum or plasma chloride re... Class II
Jul 18, 2018 Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21. The product has a stability issue which may lead to an error code indicating ... Class II
Jul 18, 2018 Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341. The product has a stability issue which may lead to an error code indicating ... Class II
Jul 17, 2018 Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The... There is a potential to generate incorrect results on the instrument if parti... Class II
Jul 17, 2018 Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: Th... There is a potential to generate incorrect results on the instrument if parti... Class II
Jul 17, 2018 Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The... There is a potential to generate incorrect results on the instrument if parti... Class II
May 16, 2018 The,K -ASSAY HP assay is intended for the quantitative determination of hum... An update to the Reagents and Specimen Collection and Handling/Preparation fo... Class II
May 16, 2018 C3 is an in vitro diagnostic assay for the quantitative determination of C3 i... An update to the Reagents and Specimen Collection and Handling/Preparation fo... Class II
May 16, 2018 Transferrin is an in vitro diagnostic assay for the quantitative determinatio... An update to the Reagents and Specimen Collection and Handling/Preparation fo... Class II
May 16, 2018 Apolipoprotein B is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation fo... Class II
May 16, 2018 Immunoglobulin G is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation fo... Class II
May 16, 2018 Immunoglobulin A is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation fo... Class II
May 16, 2018 Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determ... An update to the Reagents and Specimen Collection and Handling/Preparation fo... Class II
May 16, 2018 Immunoglobulin M is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation fo... Class II
May 16, 2018 C4 is an in vitro diagnostic assay for the quantitative determination of C4 i... An update to the Reagents and Specimen Collection and Handling/Preparation fo... Class II
Dec 8, 2017 ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the A... There is a potential to generate falsely depressed patient results in the cuv... Class II
Dec 8, 2017 ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARC... There is a potential to generate falsely depressed patient results in the cuv... Class II
Dec 8, 2017 ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARC... There is a potential to generate falsely depressed patient results in the cuv... Class II
Sep 29, 2017 Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemis... The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 ... Class II
Sep 29, 2017 ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITE... The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 ... Class II
Sep 9, 2015 ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vit... Incorrect tubing. Class II
Jan 15, 2015 ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the ... There is a potential to generate falsely-depressed patient results in the cuv... Class II
Apr 7, 2014 Lipase Reagent, 7D80. Used to measure lipase in human serum on the Archite... Package inserts have incorrect SmartWash parameters for Triglyceride. Class II
Aug 12, 2013 Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for th... Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have i... Class II
Dec 18, 2012 ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Quali... Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative an... Class II
Nov 16, 2012 Clinical Chemistry Phenobarbital, list number 1E08 Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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