Abbott Alinity m HBV AMP Kit Recall: Potential for High Negative Results

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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 the Alinity m HBV AMP Kit for possible high results in negative samples. This could lead to incorrect test outcomes, but the recall does not specify a risk of injury or serious harm.

Why it’s dangerous

The kit may produce falsely high results for negative samples, meaning tests that should show no hepatitis B virus could indicate a positive result. This could lead to incorrect diagnoses or treatment decisions.

Who’s affected

Users of the Alinity m HBV AMP Kit in the US and Europe who purchased the specific lots listed in the recall notice are affected. Laboratory staff and healthcare providers using the kit are most at risk of incorrect test results.

How to tell if you have this one

Check the lot numbers on your Alinity m HBV AMP Kit packaging. US lots include 519756, 523799, 524361, 381583, 529391, 529687, 530273, 531598. CE lots include 519755, 520957, 522137, 523798, 524059, 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Numbers
Identify the lot numbers on your Alinity m HBV AMP Kit packaging to see if they match the affected lots listed in the recall.

✎ GovInfoNow

Questions people ask

Is there a risk of injury from this kit?

The recall does not mention any risk of injury or serious harm; it only addresses potential for incorrect test results.

How do I know if my kit is affected?

Check the lot numbers on your kit packaging against the affected lots listed in the recall notice.

What should I do if my kit is affected?

The recall does not specify a remedy; you should check the lot numbers and contact Abbott if you have concerns.

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-0884-2022 — Abbott Abbott

Hello,

I own a Abbott that is covered by recall Z-0884-2022 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-0884-2022 (March 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0884-2022 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 AMP Kit (US and CE)

Lower-risk recall