Qiagen recalls SARS-CoV-2 Antigen Test kits with potential for false positives in some patient samples. Learn about affected lots and how to handle the product.
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Qiagen is recalling certain SARS-CoV-2 Antigen Test kits due to a potential for false positive results in some patient samples. This could lead to incorrect test outcomes, which may affect health decisions.
The test may produce false positive results with certain patient samples, meaning it could incorrectly indicate infection when there is none. This risk is specific to some samples and does not affect all tests equally.
People who purchased or used the recalled SARS-CoV-2 Antigen Test kits from Qiagen. Those who rely on the test for accurate results are most at risk of incorrect outcomes.
Check the lot numbers: 86651, 86652, 86653, 86654, or 86659. The product is sold with GTIN 04053228039785 and catalog number 646533.
Look for the lot numbers 86651, 86652, 86653, 86654, or 86659 on the test kit packaging.
Qiagen has become aware of the potential for false positive results with some patient samples.
Check the lot number on the test kit. If it matches 86651, 86652, 86653, 86654, or 86659, contact Qiagen for instructions.
The recall is for potential false positive results, not a physical hazard. There is no risk of injury from using the test.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-0941-2021 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-0941-2021 from Qiagen. 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.
