Abbott recalls Alinity m Resp-4-Plex Amplification Kit (CE) due to reported false positive results in respiratory virus tests. Affected kits may cause 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 Amplification Kit for possible false positive results in respiratory virus tests. This could lead to incorrect diagnoses and unnecessary treatments.
The kit may produce false positive results, meaning it could incorrectly indicate the presence of viruses like flu A, flu B, RSV, or SARS-CoV-2 when none are actually present. This might lead to unnecessary treatments or delays in proper care.
Healthcare providers using the kit for respiratory virus testing are most at risk. The recall affects kits purchased with specific lot numbers.
Check the kit's lot number on the packaging. Affected kits have lot numbers 409383, 410627, or 411921. The product is a CE-marked multiplex PCR test for respiratory viruses.
Look for lot numbers 409383, 410627, or 411921 on the packaging.
The recall is due to reports of increased reactive negative controls and false positive results in respiratory virus tests.
Check the lot number on the packaging. If it matches 409383, 410627, or 411921, stop using it and contact Abbott for guidance.
The recall record does not mention a remedy or fix for the false positive results.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1748-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1748-2025 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.
