Lower riskMedical device recall · FDA · Published December 6, 2021
Abbott Alinity m System Software Defect May Cause Incorrect Settings
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.
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Take action
Contact the company
📍Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · Des Plaines, IL 60018-3315
✎ GovInfoNow plain-language explainer
Abbott is recalling the Alinity m System with part number 08N53-002 because of a software defect that can set the Amplification Detection clamp's CLEAN position too high. This issue may lead to incorrect results in laboratory testing if the device is used without proper calibration. Read more at govinfonow.com/recall/61469-abbott-alinity-m-system-software-defect-may-cause-incorrect-settings.
“Abbott Alinity m System Software Defect May Cause Incorrect Settings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61469-abbott-alinity-m-system-software-defect-may-cause-incorrect-settings. Based on FDA recall #Z-0462-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0462-2022%22&limit=1).
The FDA announced on Dec. 6, 2021, that Abbott Molecular, Inc. is recalling the Alinity m System due to a software defect. The hazard involves the Amplification Detection clamp CLEAN position being set too high.
How to tell if you have it
Brand: Abbott Molecular
Product: Alinity m System
Part No.: 08N53-002
Model: 08N53-002
Serial numbers: all
Quantity: 742 devices
The hazard
According to the FDA, a software defect can cause the Amplification Detection clamp CLEAN position to be set too high.
Context
GovInfoNow's records show Abbott Molecular, Inc. has had 19 other recalls since Aug. 4, 2021. Other recent recalls of similar products include the Abbott Alinity m Resp-4-Plex AMP Kit (April 28, 2025), the Abbott Alinity m System (March 20, 2025), and the Abbott Alinity m HPV Kit (Sept. 12, 2024).
How to tell if you have this one
Check for the part number 08N53-002 on the Alinity m System. All units with this part number and any serial number are affected.
Brand
Abbott Molecular
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Settings
Verify the Amplification Detection clamp's CLEAN position setting to ensure it is not set too high.
How this recall unfolded
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0462-2022 (December 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0462-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.