Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0945-2022

January 09, 2022

Class II

Product summary

Firm
Acon Biotech (Hangzhou) Co., Ltd.
Event
Event 89755
Status
Ongoing
Classification
Class II
Quantity
303,760
Official record key
device-enforcement:Z-0945-2022

Official wording

Reason: 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.

Code information: Lots: COV1080201, COV1105014

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.