Acon Biotech (Hangzhou) Co., Ltd. recalls Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

Recall date

January 9, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0945-2022

FDA classification

Class II

Brand / firm

Acon Biotech (Hangzhou) Co., Ltd.

Sold / distributed

US: MD, PA International Distribution to countries of: Hungary and China.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked