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 Flowflex SARS-CoV- 2 Antigen Test Recall: Inaccurate Results Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/61289-acon-biotech-flowflex-sars-cov-2-antigen-test-recall-inaccurate. Based on FDA recall #Z-0945-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0945-2022%22&limit=1).
The FDA announced on Jan. 9, 2022, that Acon Biotech (Hangzhou) Co., Ltd. is recalling Flowflex SARS-CoV-2 Antigen Rapid Test kits because they are not authorized for emergency use and may produce inaccurate results. The agency classified the recall as Class II.
How to tell if you have it
Brand: Acon Biotech
Product: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Lot codes: COV1080201, COV1105014
Quantity: 303,760 units
The hazard
The recall involves non-EUA authorized, CE marked SARS-CoV-2 antigen rapid test kits. Use of these kits may lead to inaccurate test results, including false negative or false positive outcomes.
Context
GovInfoNow's records show other recent recalls of similar diagnostic products include the Vivoo Protein Test Recall (Nov. 22, 2025) and the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026). Additional similar product recalls listed are the Biomerieux VITEK 2 AST-N447 Kit Recall on June 4, 2026.
How to tell if you have this one
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.
Brand
Acon Biotech
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Numbers
Look for lot numbers COV1080201 or COV1105014 on the test kit packaging.
Where it went and when
Where it was distributed
Distributed in Maryland and Pennsylvania, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US: MD, PA International Distribution to countries of: Hungary and China.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Maryland, Pennsylvania.
Recall timeline
FDA published this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0945-2022 (January 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0945-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.