Device product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Z-0659-2022
Product summary
- Event
- Event 89508
- Status
- Terminated
- Classification
- Class I
- Quantity
- 243 kits (6,075 tests)
- Official record key
device-enforcement:Z-0659-2022
Official wording
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.
Code information: Lot COVGCCM0008
Distribution pattern: US distribution to CA, FL, NJ, NY, PA, SC.
Derived failure modes
-
Unknown
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.