USA Medical, LLC Recall 90098
Description: Diagnostic Kit SARS-cCo V Antigen Rapid Test
USA Medical, LLC Recall 90098 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1050-2022 |
| Event ID | 90098 |
| Event Description | Diagnostic Kit SARS-cCo V Antigen Rapid Test |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN. |
| Quantity | 2055 kits |
| Recall Reason | COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed. |
| Device Classification | 20220518 |
| Device Code Info | Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None |
| Center Classification Date | 20220506 |
| Recall Initiation Date | 20220404 |
| Recalling Firm | USA Medical, LLC |
| Initial Notification | Letter |
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