Empowered Diagnostics LLC Recall 89315
Description: CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Empowered Diagnostics LLC Recall 89315 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0480-2022 |
| Event ID | 89315 |
| Event Description | CovClear COVID-19 Rapid Antigen Test, ATG 900-031 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 284,575 units |
| Recall Reason | COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA. |
| Device Classification | 20220209 |
| Device Code Info | All lots |
| Center Classification Date | 20220128 |
| Recall Initiation Date | 20211222 |
| Recalling Firm | Empowered Diagnostics LLC |
| Initial Notification | |
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