Acon Biotech (Hangzhou) Co., Ltd. Recall 89755
Description: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Acon Biotech (Hangzhou) Co., Ltd. Recall 89755 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0945-2022 |
| Event ID | 89755 |
| Event Description | Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked |
| Product Type | Devices |
| Distribution | US: MD, PA International Distribution to countries of: Hungary and China. |
| Quantity | 303,760 |
| Recall 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. |
| Device Classification | 20220427 |
| Device Code Info | Lots: COV1080201, COV1105014 |
| Center Classification Date | 20220415 |
| Recall Initiation Date | 20220109 |
| Recalling Firm | Acon Biotech (Hangzhou) Co., Ltd. |
| Initial Notification | Letter |
| Similar To |