Z-0945-2022 Class II Ongoing
FDA device recall Z-0945-2022 was initiated by Acon Biotech (Hangzhou) Co., Ltd. on January 9, 2022 and is designated Class II. 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 te… The recall status is ongoing. Affected quantity: 303,760.
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