Abbott recalls Alinity m SARS-CoV-2 test kits (Non-US Assay) due to potential false positive results. Affected kits have specific lot numbers and expiration dates listed in the recall notice.
There is a potential for false positive results.
Abbott is recalling certain SARS-CoV-2 test kits that may produce false positive results. This means the test might incorrectly show a positive result when the person is not infected, leading to unnecessary anxiety and potential missteps in health management.
The test kits may produce false positive results, meaning they could indicate a COVID-19 infection when none exists. This can lead to unnecessary isolation, testing, and health concerns without actual infection.
People who purchased the specific Alinity m SARS-CoV-2 test kits with the listed lot numbers and expiration dates from the recall notice. Those most at risk are individuals using the test kits for home COVID-19 testing.
Check the lot numbers and expiration dates listed in the recall notice (e.g., 511468, 09/15/2021). The product includes the Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Application Specification File.
Look for the lot numbers and expiration dates listed in the recall notice to confirm if your kit is affected.
The recall does not require discarding the kits; it only identifies which kits may have false positives. You can continue using unaffected kits as normal.
Check the lot numbers and expiration dates listed in the recall notice (e.g., 511468, 09/15/2021). If your kit matches these, it is affected.
If you received a positive result from an affected kit, you should consult a healthcare provider for further testing to confirm your status.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0006-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0006-2022 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.
