Abbott recalls Alinity m Resp-4-Plex AMP Kit and Application for potential false positive results. Affected units have specific lot numbers and expiration dates. Consumers should contact Abbott for details.
There is a potential for false positive results.
Abbott is recalling two diagnostic kits that may produce false positive results. This could lead to incorrect health conclusions if used for testing. The recall affects specific lot numbers with expiration dates listed in the notice.
The kits may produce false positive results, which could lead to incorrect health conclusions. This is a potential issue with the diagnostic testing process but does not involve physical harm or immediate danger.
Users of the Alinity m Resp-4-Plex AMP Kit and Application Specification File for in vitro diagnostics are affected. Healthcare providers and labs using these kits for emergency testing are most at risk.
Check the lot numbers and expiration dates listed in the recall notice: 514074 (09/15/2021), 519243 (05/10/2022), 522088 (08/04/2022), and others. The product includes a List Number (09N79-096) and UDI code (00884999049390).
Review the lot number and expiration date on the kit to see if it matches the affected numbers listed in the recall.
The kits may produce false positive results, which could lead to incorrect health conclusions.
Check the lot numbers and expiration dates listed in the recall: 514074 (09/15/2021), 519243 (05/10/2022), 522088 (08/04/2022), and others.
Contact Abbott directly for instructions on how to proceed with the affected kits.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0005-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0005-2022 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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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.
