Abbott Alinity m System Recall: Potential for Abnormal Amplification Curves
Abbott Molecular recalls Alinity m System (Part No. 08N53-002) due to potential for abnormal amplification curves. Affected units may produce inaccurate test results.
Lower-risk recall
There is a potential for abnormal (non-sigmoidal) amplification curves.
Contact the company
What happened, in plain English
Abbott Molecular is recalling its Alinity m System (Part No. 08N53-002) because it may produce inaccurate test results due to abnormal amplification curves. This could lead to incorrect health assessments if used for diagnostic testing. Read more at govinfonow.com/recall/61465-abbott-alinity-m-system-recall-potential-for-abnormal-amplification-curves.
Source Summary by GovInfoNow · govinfonow.com/recall/61465-abbott-alinity-m-system-recall-potential-for-abnormal-amplification-curves · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0460-2022
Cite this page
“Abbott Alinity m System Recall: Potential for Abnormal Amplification Curves.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61465-abbott-alinity-m-system-recall-potential-for-abnormal-amplification-curves. Based on FDA recall #Z-0460-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0460-2022%22&limit=1).
Why it’s dangerous
The device may generate abnormal amplification curves during testing, which can cause inaccurate results. This could lead to incorrect health assessments if the system is used for diagnostic purposes. The issue does not involve physical harm but affects test accuracy.
Who’s affected
Users of the Alinity m System for diagnostic testing are affected. Laboratory professionals and healthcare providers using this device for clinical testing are most at risk of inaccurate results.
How to tell if you have this one
Check for the model number 08N53-002 and all serial numbers on the Alinity m System. The recall applies to all units sold with this specific part number.
- Brand
Abbott Molecular- Category
Medical device
What to do — step by step
Check Device Model
Identify the model number on your Alinity m System to confirm if it is 08N53-002.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this device?
No action is required beyond checking the model number. The recall does not require immediate discontinuation.
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Where this comes from
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-0460-2022 (December 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0460-2022 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.