Abbott Molecular Alinity m System Part 08N53-002 Firmware Issue
Abbott Molecular recalls Alinity m System with Part No. 08N53-002 due to potential camera firmware installation issues. 74 impacted units identified.
Lower-risk recall
There is an issue with the installation of updated camera firmware on the system.
Contact the company
What happened, in plain English
Abbott Molecular is recalling 74 units of the Alinity m System with Part No. 08N53-002 because of a camera firmware installation issue. This could affect the system's proper operation. Read more at govinfonow.com/recall/61470-abbott-molecular-alinity-m-system-part-08n53-002-firmware-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/61470-abbott-molecular-alinity-m-system-part-08n53-002-firmware-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0463-2022
Cite this page
“Abbott Molecular Alinity m System Part 08N53-002 Firmware Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61470-abbott-molecular-alinity-m-system-part-08n53-002-firmware-issue. Based on FDA recall #Z-0463-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0463-2022%22&limit=1).
Why it’s dangerous
The issue involves the installation of updated camera firmware on the system. This could lead to improper operation of the camera, potentially affecting test accuracy or system functionality.
Who’s affected
Users of the Alinity m System with Part No. 08N53-002 are affected. Laboratory or medical professionals who use this system for testing are most at risk.
How to tell if you have this one
Check if your Alinity m System has Part No. 08N53-002. The impacted units have specific serial numbers listed in the recall notice.
- Brand
Abbott Molecular- Product
Alinity m System, Part No. 08N53-002- Category
Medical device
What to do — step by step
Check System Serial Number
Identify your Alinity m System's serial number to see if it matches the listed impacted numbers.
Where it went and when
Where it was distributed
Distributed in 15 states and D.C., and outside the U.S.
FDA distribution: “Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy, Malaysia, Mozambique, Portugal, South Africa,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, District of Columbia, Georgia, Illinois, Kentucky, Maryland, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Rhode Island, South Dakota, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0463-2022 (December 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0463-2022 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.