Abbott Alinity m HBV File May Cause Incorrect Negative Results

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Contact the company & request your remedy

Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · 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 is recalling Alinity m HBV Application Specification Files that may produce incorrect negative results. This could lead to false negatives in hepatitis B virus testing, potentially missing infections.

Why it’s dangerous

The files may cause the testing system to misquantitate negative samples, resulting in false positive results. This could lead to incorrect conclusions about hepatitis B status, potentially missing infections.

Who’s affected

Users of the Alinity m HBV Application Specification Files for hepatitis B testing. Those who rely on these files for accurate test results may be at risk of false negatives.

How to tell if you have this one

Check if you have the Alinity m HBV Application Specification File with list numbers 08N47-03A (US, v1.00), 08N47-01B (CE, v2.00), or 08N47-01C (CE, v3.00).

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check File Version
Identify the version number on your Alinity m HBV Application Specification File to confirm if it is affected.

✎ GovInfoNow

Questions people ask

What could happen if I use the recalled files?

The files may cause incorrect negative results in hepatitis B tests, potentially missing infections.

How do I know if I have the recalled files?

Check the list numbers: 08N47-03A (US, v1.00), 08N47-01B (CE, v2.00), or 08N47-01C (CE, v3.00).

Do I need to do anything with the files?

The recall does not specify a remedy, so no action is required beyond checking the file version.

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-0883-2022 — Abbott Abbott

Hello,

I own a Abbott that is covered by recall Z-0883-2022 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-0883-2022 (March 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0883-2022 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 HBV Application Specification File (US and CE)

Lower-risk recall