Flowflex SARS-CoV-2 Antigen Rapid Test recall
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Why was Flowflex SARS-CoV-2 Antigen Rapid Test 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: COV1080201, COV1105014
- Product
- Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
- Recalling firm
- Acon Biotech (Hangzhou) Co., Ltd.
- Quantity
- 303,760
- Distribution
- US: MD, PA International Distribution to countries of: Hungary and China.
- Recall date
- April 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)