Abbott Alinity C Chemistry Analyzer May Give Incorrect Test Results

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Recalling firmAbbott Gmbh & Co. KGMax-Planck-Ring 2, 65205 · Wiesbaden, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Abbott is recalling its Alinity C chemistry analyzer processing modules because they may produce incorrect test results for certain blood tests. This could lead to wrong medical decisions if the tests are used without correction.

Why it’s dangerous

The processing modules may generate incorrect results for four specific blood tests. This could cause wrong medical decisions if the tests are used without correction.

Who’s affected

People who use the Alinity C processing modules for blood tests at home or in clinics may be affected. Those with specific blood tests listed are most at risk.

How to tell if you have this one

The Alinity C processing module has a serial number. All units are affected, as indicated by the list number 03R67-01.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for the serial number on the Alinity C processing module to confirm it is affected.

✎ GovInfoNow

Questions people ask

What blood tests might be affected?

Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Gl: Glutamyl Transferase tests.

How can I tell if my Alinity C module is affected?

All units are affected, as indicated by the list number 03R67-01. Check the serial number on the module.

What should I do if I have the affected module?

The recall record does not specify a remedy, so contact Abbott directly for guidance.

Take action

Contact Abbott

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

✉️ Open in email

Subject: Recall Z-2401-2020 — Abbott Abbott

Hello,

I own a Abbott that is covered by recall Z-2401-2020 from Abbott.

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-2401-2020 (May 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2401-2020 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 Gmbh & Co. KG recalls Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

Lower-risk recall