CELLTRION USA INC Recall 89508
Description: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC Recall 89508 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0659-2022 |
| Event ID | 89508 |
| Event Description | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 |
| Product Type | Devices |
| Distribution | US distribution to CA, FL, NJ, NY, PA, SC. |
| Quantity | 243 kits (6,075 tests) |
| Recall Reason | The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021. |
| Device Classification | 20220309 |
| Device Code Info | Lot COVGCCM0008 |
| Center Classification Date | 20220302 |
| Recall Initiation Date | 20211228 |
| Recalling Firm | CELLTRION USA INC |
| Similar To |