Device product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Z-0731-2022
Product summary
- Event
- Event 89640
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,228,200 tests
- Official record key
device-enforcement:Z-0731-2022
Official wording
Reason: Kits were labeled with incorrect expiration dates.
Code information: Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007
Distribution pattern: The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.
Derived failure modes
-
Unknown
Kits were labeled with incorrect expiration dates.