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Acon Biotech (Hangzhou) Co., Ltd. Recall 89755

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

Acon Biotech (Hangzhou) Co., Ltd. Recall 89755 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0945-2022
Event ID89755
Event DescriptionFlowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Product TypeDevices
DistributionUS: MD, PA International Distribution to countries of: Hungary and China.
Recall ReasonNon-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.
Device Classification20220427
Device Code InfoLots: COV1080201, COV1105014
Center Classification Date20220415
Recall Initiation Date20220109
Recalling FirmAcon Biotech (Hangzhou) Co., Ltd.
Initial Notification Letter
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