Migo Trading LLC Recall 89028
Description: FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Migo Trading LLC Recall 89028 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0421-2022 |
| Event ID | 89028 |
| Event Description | FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test |
| Product Type | Devices |
| Distribution | NY |
| Quantity | 200,100 units |
| Recall 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. |
| Device Classification | 20220105 |
| Device Code Info | UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023 |
| Center Classification Date | 20211227 |
| Recall Initiation Date | 20211104 |
| Recalling Firm | Migo Trading LLC |
| Initial Notification | Letter |
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