medical Class II Updated 2022-04-27

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

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: MD, PA
Lot/Code Info: Lots: COV1080201, COV1105014
View official government recall

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