CELLTRION USA INC Recall 89516
Description: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC Recall 89516 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0680-2022 |
| Event ID | 89516 |
| Event Description | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 |
| Product Type | Devices |
| Distribution | Distributed to TX. |
| Quantity | 8080 kits originally distributed; 726 kits redistributed |
| Recall Reason | Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis. |
| Device Classification | 20220309 |
| Device Code Info | Lots COVGCCF0001, COVGCCF0002 |
| Center Classification Date | 20220302 |
| Recall Initiation Date | 20211202 |
| Recalling Firm | CELLTRION USA INC |
| Initial Notification | |
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