Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Recall
- Recall Number
- Z-0945-2022
- Event Number
- 89755
- Firm
- Acon Biotech (Hangzhou) Co., Ltd.
- FEI Number
- 3002829675
- Product Code
- QKP
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- January 9, 2022
- Address
- 398 Tianmushan Road, Hangzhou, China
Description
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.
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, [email protected] 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/
US: MD, PA International Distribution to countries of: Hungary and China.
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