Abbott recalls Alinity m SARS-CoV-2 test kits that may produce false positive results. Affected kits have specific lot numbers and expiration dates. Consumers should check their kit's serial number and expiration date.
There is a potential for false positive results.
Abbott is recalling Alinity m SARS-CoV-2 test kits that may give false positive results. This could lead to unnecessary quarantine or anxiety if the test incorrectly shows a positive result for COVID-19.
The test kits may produce false positive results, meaning they could indicate a COVID-19 infection when none exists. This can cause unnecessary stress and quarantine for people who test positive but are actually healthy.
People who own or use the Alinity m SARS-CoV-2 test kits with the listed lot numbers and expiration dates are affected. Those most at risk are individuals who rely on these tests for home COVID-19 screening.
Check the kit's serial number and expiration date. Affected kits have specific lot numbers and expiration dates listed in the recall notice, such as 511810 (expiration 09/18/2021) or 527399 (expiration 01/28/2023).
Look for the serial number and expiration date on the test kit packaging to determine if it is affected.
No, the recall does not require discarding the kits. You can check if your kit is affected by its serial number and expiration date.
If your test kit shows a positive result, follow standard procedures for positive tests, such as contacting a healthcare provider or getting tested again.
Check the serial number and expiration date on your test kit. Affected kits have specific lot numbers and expiration dates listed in the recall notice.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0004-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0004-2022 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.
