CELLTRION USA INC Recall 89965
Description: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC Recall 89965 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0953-2022 |
| Event ID | 89965 |
| Event Description | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 12,632 kits |
| Recall Reason | Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. |
| Device Classification | 20220504 |
| Device Code Info | All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022. |
| Center Classification Date | 20220427 |
| Recall Initiation Date | 20220401 |
| Recalling Firm | CELLTRION USA INC |
| Initial Notification | Letter |
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