FDA Device

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

Hazard

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 You Should Do

Remedy

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/

Products

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Brand
Acon Biotech (Hangzhou) Co., Ltd.
UPC
Lots: COV1080201, COV1105014

Units Affected

303,760