Acon Biotech (Hangzhou) Co., Ltd. recalls Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
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.
Read the official notice →- Date
- 2022-04-27
- Country
- United States
- Brand
- Acon Biotech (Hangzhou) Co., Ltd.
- Product
- Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
- Classification
- Class II
- Units
- US: MD, PA International Distribution to countries of: Hungary and China.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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