Acon Biotech (Hangzhou) Co., Ltd. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 04/04/22, recall notices were sent to distributor customers who were asked to do the following: If you may have further distributed this product, please identify your customers and notify them at once of this product correction. Your notification to your customers may be enhanced by including a copy of this correction notification letter. This correction should be carried out to the consumer/user level in U.S. Complete and return the response form to the recalling firm. Customers with additional questions were encouraged to contact Denice Dong, Denice.Dong@aconlab.com.cn Additional instructions in a press release were provided to address affected non-EUA devices, of unknown quantity, that may have entered the U.S. market. It is recommended to stop use and dispose of affected devices in the U.S. market: https://www.aconlabs.com/news/

Distribution

As reported by FDA

MD, PA