Z-0945-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- January 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 303,760
Product Description
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.
Distribution Pattern
US: MD, PA International Distribution to countries of: Hungary and China.
Code Information
Lots: COV1080201, COV1105014