FDA Device recall Z-0945-2022
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked by Acon Biotech Hangzhou, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0945-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-09 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Acon Biotech Hangzhou |
| Distribution | MD, PA |
Product
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Reason
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.
Identifiers
| code_info | Lots: COV1080201, COV1105014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0945-2022%22
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