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Acon Biotech (Hangzhou) Co., Ltd. recalls Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Recalled April 27, 2022 · FDA recall Z-0945-2022 · Acon Biotech (Hangzhou)
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. · FDA Class II
Units
303,760
Sold at
US: MD, PA International Distribution to countries of: Hungary and China.
Description
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.
Product
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Manufacturer(s)
Acon Biotech (Hangzhou) Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →