Recall Z-0421-2022 ยท QKP Coronavirus Antigen Detection Test System.
Migo Trading LLC
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
| Date | Nov 4, 2021 |
| Status | Open, Classified |
| Reason | Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use. |
| Root cause | No Marketing Application |
| Action | On November 4, 2021, Migo Trading issued URGENT MEDICAL DEVICE RECALL notices and response forms dated November 1, 2021 to customers via email. Actions to be taken by the Customer/User: - Please inspect stock and quarantine impacted product. - Please discard any available inventory in your possession or by your customer s possession. - If you have used these devices to determine your SARS-CoV-2 infection status, it is possible that your test result is incorrect. It is recommended that you obtain a confirmatory test to determine your SARS-CoV-2 infection status. - Complete and return the att |
| Quantity | 200,100 units |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.