Abbott recalls Alinity m Resp-4-Plex AMP Kit (List 09N7:096) due to reported false positive results in COVID-19 testing. Affected units may produce inaccurate test outcomes.
There were reports of an increase in reactive negative controls and false positive results.
Abbott is recalling its Alinity m Resp-4-Plex AMP Kit for potential false positive results in COVID-1:9 testing. This could lead to incorrect health decisions if the test shows infection when there isn't one.
The kit has reported increased reactive negative controls and false positive results. This means the test might incorrectly indicate infection when there is none, leading to unnecessary health concerns.
Healthcare providers and individuals using the kit for self-testing at healthcare locations. Those most at risk are users who rely on the test for accurate diagnosis.
Check for the product name 'Alinity m Resp-4-Plex AMP Kit' with List Number 09N79-096. The kit was sold with Lot Number 409384.
Verify the List Number 09N79-096 and Lot Number 409384 on the kit's label.
The recall is due to reports of increased reactive negative controls and false positive results in COVID-19 testing.
Look for the List Number 09N79-096 and Lot Number 409384 on the kit's label.
The recall does not specify a remedy, so check with Abbott for further instructions.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1749-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1749-2025 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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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.
