Abbott recalls Alinity m Resp-4-Plex AMP Kit (Non-US Assay) due to potential for false positive results in in vitro diagnostic testing. Affected units include specific lot numbers from 2021-2023.
There is a potential for false positive results.
Abbott is recalling its Alinity m Resp-4-Plex AMP Kit (Non-US Assay) because it may produce false positive results in diagnostic testing. This could lead to incorrect health conclusions if used without proper verification.
The kit may produce false positive results, meaning it could indicate a condition is present when it isn't. This could lead to unnecessary health concerns or incorrect treatment decisions if not verified through additional testing.
Users of this in vitro diagnostic kit for respiratory testing are affected. Those who have the specific lot numbers listed in the recall are most at risk of receiving inaccurate test results.
Check the kit's lot number on the packaging, which is listed in the recall as 513424 through 527845. The product is an in vitro diagnostic kit for respiratory testing.
Look for the lot number on the packaging, which should match one of the listed numbers from 513424 to 527845.
The kit may produce false positive results, which could lead to incorrect health conclusions if not verified through additional testing.
Check the lot number on the packaging; affected units have lot numbers from 513424 to 527845 as listed in the recall.
The recall does not specify a remedy, so you may continue using it but should verify results with another test if concerns arise.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0008-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0008-2022 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.
