Abbott recalls Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) due to potential false positive results. Affected units have specific lot numbers and expiration dates. Consumers should check their kit details.
There is a potential for false positive results.
Abbott is recalling its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) because it may produce false positive results. This could lead to incorrect COVID-19 test outcomes, which might cause unnecessary anxiety or actions.
The kit may produce false positive results, meaning it could indicate a COVID-19 infection when none exists. This can lead to unnecessary isolation, testing, or health concerns. The false positives are not guaranteed but are a potential risk with the specific lot numbers.
People who purchased the Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) for at-home COVID-19 testing are affected. Those who use the kit for testing are most at risk of receiving inaccurate results.
Check the kit's lot number and expiration date on the packaging. The affected kits have specific lot numbers listed in the recall notice, such as 520596 (expiration 06/18/2022) and others up to 527842 (expiration 02/08/2023).
Look for the lot number and expiration date on the packaging to determine if your kit is affected.
The recall is due to a potential for false positive results, which could lead to incorrect COVID-19 test outcomes.
Check the lot number and expiration date on the packaging to see if it's affected. If it is, you may need to contact Abbott for further instructions.
The recall is for potential false positives, not physical safety risks. There are no immediate health hazards from using the kit.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0007-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0007-2022 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.
