Flowflex SARS-CoV-2 Antigen Rapid Test — Class II medical device recall Z-0945-2022
Ongoing recall by Acon Biotech (Hangzhou) Co., Ltd., reported 2022-04-27, distributed in MD, PA. Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market beca
| Recall number | Z-0945-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acon Biotech (Hangzhou) Co., Ltd., Hangzhou, China |
| Recall initiated | 2022-01-09 |
| Classified | 2022-04-15 |
| Reported by FDA | 2022-04-27 |
| Distributed | MD, PA |
| Countries outside the US | CN, HU |
| Quantity | 303,760 |
| Lot numbers | COV1080201, COV1105014 |
Product
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0945-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.