Abbott Laboratories, Inc recalls
Every recall we track for Abbott Laboratories, Inc — 26 in all, from 2017–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Abbott Laboratories, Inc peaked in 2018 (17); 26 since 2017.
All FDA recall records for Abbott Laboratories, Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 5 | 0 | 5 |
| 2018 | 0 | 1 | 16 | 0 | 17 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Abbott Laboratories, Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Abbott Laboratories, Inc recalls
12 shown- Lower riskMedical device
Abbott Laboratories, Inc recalls Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended
Abbott recalls Alinity s System software version 2.8.0 (serials AS1001-AS1368) due to wash buffer error causing potential inaccurate test results. This is an in vitro diagnostic device.
AbbottFeb 3, 2022 - Use cautionMedical device
Abbott Laboratories, Inc recalls Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening,
Abbott recalls Alinity s System REF 06P16-01 due to liquid waste pressure buildup that may spray users. Affected units have serial numbers AS1001 to AS1330.
AbbottJul 12, 2021 - Lower riskMedical device
Abbott Laboratories, Inc recalls ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated
Abbott recalls ARCHITECT C System Mixer models LN 09D59-01, 02, 03 due to risk of mixer blade detaching, which can cause inadequate sample mixing in clinical chemistry tests.
AbbottMay 1, 2019 - Lower riskMedical device
Abbott Laboratories, Inc recalls ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in
Abbott recalls specific ARCHITECT Magnesium test kits that may give inaccurate low results for magnesium in urine. Affected kits have lot numbers listed in the recall notice.
AbbottJan 2, 2019 - Use cautionMedical device
Abbott Laboratories, Inc recalls APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Abbott recalls APS Accelerator modular systems with missing safety pacemaker labels. These systems require 200mm distance from pacemaker users to prevent malfunction risks.
AbbottSep 7, 2018 - Lower riskMedical device
Abbott Laboratories, Inc recalls Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip
Abbott recalls ARCHITECT cSystems ICT Module REF 09D28-03 for potential false elevated chloride test results. Affected units may give inaccurate blood chloride readings.
AbbottAug 28, 2018 - Lower riskMedical device
Abbott Laboratories, Inc recalls Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Abbott recalls ARCHITECT Creatine Kinase IVD with potential stability issues causing error codes and QC failures. Affected units include specific lot numbers and expiration dates.
AbbottJul 18, 2018 - Lower riskMedical device
Abbott Laboratories, Inc recalls Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for
Abbott recalls ARCHITECT c4000 Processing Module (List No. 02P24) due to potential incorrect test results if error codes aren't resolved before running tests. Affected units may need correction to ensure accurate diagnostic results.
AbbottJul 17, 2018 - Lower riskMedical device
Abbott Laboratories, Inc. recalls CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital
Abbott recalls CardioMEMS HF System Patient Electronics (Model CM1100) and Hospital Electronics (Model CM3000) units that may display false Error 5 messages due to a configuration issue. Affected units have specific serial numbers listed in the recall.
AbbottJun 14, 2018 - Lower riskMedical device
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
Abbott recalls C4 diagnostic assay kits requiring updated instructions due to handling issues. Learn what to do if you have this product.
AbbottMay 16, 2018 - Lower riskMedical device
Abbott Laboratories, Inc recalls ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There
Abbott recalls ARCHITECT c8000 Cuvette Segments (Part #01G46-01/01G06) that may cause falsely low test results. Affected units include 165 cuvettes per reaction carousel. Consumers should contact Abbott for details.
AbbottDec 8, 2017 - Lower riskMedical device
Abbott Laboratories, Inc recalls ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical
Abbott recalls ARCHITECT c4000, c8000, and c16000 clinical chemistry systems due to potential tubing leaks from a manufacturing issue with the peristaltic head tubing connector.
AbbottSep 29, 2017
Abbott Laboratories, Inc recall questions
How many recalls has Abbott Laboratories, Inc had?
26 recalls from Abbott Laboratories, Inc are on record with U.S. safety agencies, from 2017–2022.
What is the most recent Abbott Laboratories, Inc recall?
Abbott Laboratories, Inc recalls Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended, dated Feb 3, 2022. Every Abbott Laboratories, Inc recall is listed on this page, newest first.
What should I do if I have a recalled Abbott Laboratories, Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Abbott Laboratories, Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.