Abbott recalls Alinity m Resp-4-Plex Amp Kit (lot numbers 381177, 525460, etc.) due to reports of false positive results. Consumers should check their kit's lot number and contact Abbott for guidance.
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Abbott is recalling certain Alinity m Resp-4-Plex Amp Kits because they may cause false positive results in tests. This could lead to incorrect health diagnoses if used improperly.
The kits may produce false positive results when used with certain lots, which could lead to incorrect health diagnoses. This happens due to issues with the negative controls in the testing process.
Users of the Alinity m Resp-4-Plex Amp Kit for laboratory testing are affected. Those with the specific lot numbers listed in the recall are most at risk.
Check the kit's lot number on the packaging. Affected lots include 381177 (exp 8/24/2023), 525460, 525766, 526393, 526483, 527142, 527403, 527602, and 531612.
Look for the lot number on the packaging to determine if it is affected.
Abbott reports an increase in reactive negative controls and false positive results with certain lots of Alinity m Resp-4-Plex AMP kits.
Check your kit's lot number and contact Abbott for guidance on next steps.
The recall is due to potential false positive results, which could lead to incorrect health diagnoses, but no immediate safety risks are reported.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0740-2023 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0740-2023 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.
