Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
This recall is currently active, issued January 9, 2022. It was issued by Acon Biotech (Hangzhou) Co., Ltd..
- Recall Initiated
- January 9, 2022
- Recall Number
- Z-0945-2022
- Quantity
- 303,760
- Firm Location
- Hangzhou, China
- Official Source
- View on FDA website ↗
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.
Distribution
US: MD, PA International Distribution to countries of: Hungary and China.
Lot / Code Info
Lots: COV1080201, COV1105014
Root Cause
No Marketing Application
Action Taken
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/