Acon Biotech recalls CE-marked SARS-CoV-2 antigen rapid tests due to potential false negatives or positives. Consumers should check lot numbers COV1080201 and COV1105014 for affected units.
Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.
Acon Biotech is recalling CE-marked SARS-CoV-2 antigen rapid test kits sold in the U.S. because they may give inaccurate results, including false negatives or false positives. This could lead to incorrect health decisions if someone relies on the test.
The test kits are non-EUA authorized but CE marked, meaning they were approved in Europe but not in the U.S. This can cause the tests to give false negative or false positive results, leading to incorrect health decisions.
Anyone who purchased the recalled Flowflex SARS-CoV-2 Antigen Rapid Test kits from the U.S. market. People who use these tests for self-testing are most at risk of getting incorrect results.
Check the lot numbers on the test kit: COV1080201 or COV1105014. The product is a CE-marked SARS-CoV-2 antigen rapid test for self-testing.
Look for lot numbers COV1080201 or COV1105014 on the test kit packaging.
The recall is due to potential inaccurate results, not safety issues. The tests are non-EUA authorized but CE marked, which may lead to false negatives or positives.
Check the lot numbers on the test kit: COV1080201 or COV1105014.
The recall does not specify a remedy, so no action is required beyond checking the lot numbers.
We’ve drafted a message you can send Acon Biotech to request your refund or repair — edit it as you like.
Subject: Recall Z-0945-2022 — Acon Biotech Acon Biotech Hello, I own a Acon Biotech that is covered by recall Z-0945-2022 from Acon Biotech. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
