Recall Z-0945-2022— Acon Biotech (Hangzhou) Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Acon Biotech (Hangzhou) Co., Ltd., initiated 2022-01-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked. 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..
- Recalling firm
- Acon Biotech (Hangzhou) Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-09
- Firm location
- Hangzhou, China
Product description
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.