Abbott Molecular Alinity m System Part 08N53-002 Firmware Issue

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Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave, N/A · Des Plaines, IL 60018-3315

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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
Category
Medical device

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

How many units are affected?

74 units with specific serial numbers are affected.

What is the camera firmware issue?

The issue involves potential problems with installing updated camera firmware on the system.

Do I need to stop using the system?

No, the recall does not require stopping use; it's a firmware installation issue that may affect operation.

Take action

Contact Abbott Molecular

We’ve drafted a message you can send Abbott Molecular to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0463-2022 — Abbott Molecular Abbott Molecular

Hello,

I own a Abbott Molecular that is covered by recall Z-0463-2022 from Abbott Molecular.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Abbott Molecular, Inc. recalls Alinity m System, Part No. 08N53-002

Lower-risk recall