Abbott recalls specific lots of Alinity m Resp-4-Plex Amp Kit due to increased false positive results. Affected units may cause inaccurate test results.
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 lots of Alinity m Resp-4-Plex Amp Kit because they may produce false positive results. This could lead to incorrect test outcomes, especially in medical testing scenarios.
The recalled kits may show false positive results due to reactive negative controls. This can cause inaccurate test outcomes, potentially leading to incorrect medical decisions.
Healthcare professionals using the Alinity m Resp-4-Plex Amp Kit for medical testing are most affected. Patients relying on accurate test results could be impacted by false positives.
Check for the part number 09N79-096 on the kit. Affected lots include 381465 (exp 8/24/2023), 524433 (exp 1/5/2023), 526710 (exp 1/21/2023), and 527845 (exp 2/8/2023).
Identify the lot number on the kit to determine if it is affected.
The recall is due to reports of increased false positive results with certain lots of Alinity m Resp-4-Plex Amp Kit.
The official notice does not specify a remedy for affected kits.
Check the lot number: 381465 (exp 8/24/2023), 524433 (exp 1/5/2023), 526710 (exp 1/21/2023), or 527845 (exp 2/8/2023).
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0739-2023 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0739-2023 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.
