Abbott Molecular, Inc. recalls
Every recall we track for Abbott Molecular, Inc. — 30 in all, from 2021–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Abbott Molecular, Inc. halved in 2025 (3, down from 6 in 2024).
All FDA recall records for Abbott Molecular, 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 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 10 | 0 | 10 |
| 2022 | 0 | 0 | 10 | 0 | 10 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 5 | 1 | 6 |
| 2025 | 0 | 1 | 2 | 0 | 3 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Abbott Molecular, Inc. recalls
What to do if you have a recalled Abbott Molecular, 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 Molecular, Inc. recalls
20 shown- Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain
Abbott recalls Alinity m Resp-4-Plex AMP Kit (List 09N7:096) due to reported false positive results in COVID-19 testing. Affected units may produce inaccurate test outcomes.
AbbottApr 28, 2025 - Use cautionMedical device
Abbott Molecular, Inc. recalls The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall
Abbott recalls Alinity m System models 08N53-001, 08N53-002, and 08N53-032 (refurbished) due to liquid waste potentially flowing into walking paths. All units with these serial numbers are affected.
AbbottMar 20, 2025 - Lower riskMedical device
Abbott Molecular, Inc. recalls Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF
Abbott recalls Alinity m HPV AMP Kit (product codes REF 09N15-095, 09N15-090, 09N15-091) due to potential false negative results from iron leaching in the lysis solution.
AbbottSep 12, 2024 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m System, Part Number: 08N53-002
Abbott recalls Alinity m System (part 08N53-002) due to error message when using Copan UTM-RT tubes, which may cause incorrect test results.
AbbottMar 20, 2024 - UnratedMedical device
Abbott Molecular, Inc. recalls Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Abbott Molecular recalls M1000 Wash Station Assembly & DITI Slide (REF 04J72-28) shipped to U.S. customers without U.S. approval. This export-only product may not meet U.S. specifications.
Abbott MolecularFeb 1, 2024 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro
Abbott recalls Alinity m HCV AMP kits with specific lot numbers due to increased false positives in hepatitis C testing. Affected kits may produce inaccurate results, requiring replacement.
AbbottOct 30, 2023 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes
Abbott recalls Alinity m System devices with potential calibration errors that could misconfigure testing results. Affected units may need recalibration or correction.
AbbottDec 9, 2022 - Lower riskMedical device
Abbott Molecular, Inc. recalls Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Abbott recalls specific lots of Alinity m Resp-4-Plex Amp Kit due to increased false positive results. Affected units may cause inaccurate test results.
AbbottNov 22, 2022 - Lower riskMedical device
Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Abbott recalls Alinity m System with specific serial numbers due to potential for incorrect results after calibration. Affected units may need recalibration to ensure accurate test results.
AbbottNov 11, 2022 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Abbott recalls Alinity m System software version 1.6.5 for potential test errors. Affected units may have waste chute issues, barcode misreads, or calibration problems. Contact Abbott for details.
AbbottOct 12, 2022 - Lower riskMedical device
Abbott Molecular, Inc. recalls Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In
Abbott recalls Alinity m SARS-CoV-2 Control Kits (REF 09N78-085) due to reported message code 9186 errors. Affected kits may show internal control failures during testing.
AbbottAug 19, 2022 - Lower riskMedical device
Abbott Molecular, Inc. recalls The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Abbott recalls Alinity m System (REF 08N53-002) for incorrect optical calibration that may affect diagnostic accuracy. No immediate action needed but check for serial number 00654.
Abbott MolecularJul 19, 2022 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)
Abbott recalls Alinity m HBV AMP Kit (US and CE) due to potential misquantitation causing high results for negative samples. Affected lots listed in the recall notice.
AbbottMar 4, 2022 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m Integrated Reaction Units (IRU)
Abbott recalls Alinity m Integrated Reaction Units with potential for Reaction Vessels to detach from caps during pipettor robot transport. Affected units have specific lot numbers. Consumers should contact Abbott for details.
AbbottFeb 11, 2022 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
Abbott Molecular recalls Alinity m System with Part No. 08N53-002 due to potential camera firmware installation issues. 74 impacted units identified.
Abbott MolecularDec 6, 2021 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
Abbott recalls Alinity m System with part number 08N53-002 due to a software defect that may cause incorrect settings in the Amplification Detection clamp. Affected units include all serial numbers of this model.
Abbott MolecularDec 6, 2021 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
Abbott recalls Alinity m System model 08N53-002 due to software issues affecting field service maintenance procedures. Affected units may require specific software updates to prevent improper maintenance.
Abbott MolecularDec 6, 2021 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002
Abbott Molecular recalls Alinity m System (Part No. 08N53-002) due to potential for abnormal amplification curves. Affected units may produce inaccurate test results.
Abbott MolecularDec 6, 2021 - Lower riskMedical device
Abbott Molecular, Inc. recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) due to potential false positive results. Affected units have specific lot numbers and expiration dates. Consumers should check their kit details.
AbbottSep 2, 2021 - Lower riskMedical device
Abbott Molecular, Inc. recalls Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI
Abbott recalls Vysis CLL FISH Probe Kits that may not detect 13q deletions in cancer samples. Affected kits have specific part numbers and lot codes. Contact Abbott for details.
AbbottAug 4, 2021
Abbott Molecular, Inc. recall questions
How many recalls has Abbott Molecular, Inc. had?
30 recalls from Abbott Molecular, Inc. are on record with U.S. safety agencies, from 2021–2025.
What is the most recent Abbott Molecular, Inc. recall?
Abbott Molecular, Inc. recalls Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain, dated Apr 28, 2025. Every Abbott Molecular, Inc. recall is listed on this page, newest first.
Why are Abbott Molecular, Inc. products recalled?
The most common reasons on record: There is a potential for false positive results. (5).
What should I do if I have a recalled Abbott Molecular, 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 Molecular, 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.