Quidel recalls Sofia SARS Antigen FIA IVD REF 20374 due to false positive results. Affected units include specific model and lot numbers.
Due to false positive results.
Quidel is recalling its Sofia SARS Antigen FIA test kits (model 20374) because they can produce false positive results. This means the test might incorrectly show a positive result for SARS when there's no infection, which could lead to unnecessary anxiety or actions.
The test kits can produce false positive results, meaning they might indicate a SARS infection when there is none. This could cause unnecessary worry or actions like seeking unnecessary medical care. The false positives are due to a manufacturing issue with the test's internal components.
People who purchased or use the QUIDEL Sofia SARS Antigen FIA test kits with model number 203: 168365 through 166817. Those most at risk are individuals relying on these tests for SARS screening.
Check the model number on the test kit, which should be 20374. Look for lot numbers between 706142 and 166817. The product was sold with UPC A GTIN-12: 0 14613 33908 2.
Look for model number 20374 on the test kit packaging.
Ensure the lot number is between 706142 and 166817 to confirm it's affected.
The test kits can produce false positive results, meaning they might incorrectly show a SARS infection when there is none.
The recall record does not specify a remedy, so no action is required unless the test kit has a model number of 20374 and a lot number between 706142 and 166817.
Check the model number (20374) and lot number (between 706142 and 166817) on the test kit packaging.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-0428-2021 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-0428-2021 from Quidel. 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.
