Device product
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Z-0945-2022
Product summary
- Event
- Event 89755
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 303,760
- Official record key
device-enforcement:Z-0945-2022
Official wording
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.
Code information: Lots: COV1080201, COV1105014
Distribution pattern: US: MD, PA International Distribution to countries of: Hungary and China.
Derived failure modes
-
Unknown
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.