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 |
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