Wondfo USA Co Ltd Recall 94261
Description: Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Wondfo USA Co Ltd Recall 94261 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2030-2024 |
| Event ID | 94261 |
| Event Description | Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 1,238,755 units |
| Recall Reason | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers. |
| Device Classification | 20240619 |
| Device Code Info | a) PRE-STA-25, UDI/DI **, Lot Numbers: W03921102, W039301003, W039301005, W039301004, W039309003, W039309007, W03910902, W03911002, W03910911, W03921005, W03921102, W03921008, W039212001, W039212006, W03920804; b) PRE-STA-10, UDI/DI **, Lot Numbers: W03920902, W03921103, W039307002, W039306008, W03931002 |
| Center Classification Date | 20240607 |
| Recall Initiation Date | 20240422 |
| Recalling Firm | Wondfo USA Co Ltd |
| Initial Notification | Letter |
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