Recall Z-0945-2022 ยท QKP Coronavirus Antigen Detection Test System.
Acon Biotech (Hangzhou) Co., Ltd.
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
| Date | Jan 9, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | No Marketing Application |
| Action | 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 ins |
| Quantity | 303,760 |
| Distribution | US: MD, PA International Distribution to countries of: Hungary and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.