April 27, 2022Medical DevicesFDA
Acon Biotech (Hangzhou) Co., Ltd. recalls Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Hazard: 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.