FDA-Device2022-04-27Class II
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Acon Biotech (Hangzhou) Co., Ltd.
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.
Sold states
US: MD, PA International Distribution to countries of: Hungary and China.
Affected count
303,760
Manufactured in
398 Tianmushan Road, Hangzhou, China
Products
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0945-2022Don't want to check this manually?
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