Z-0731-2022 Class II Ongoing
FDA device recall Z-0731-2022 was initiated by CELLTRION USA INC on February 25, 2022 and is designated Class II. Reason for recall: Kits were labeled with incorrect expiration dates. The recall status is ongoing. Affected quantity: 1,228,200 tests.
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- February 25, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,228,200 tests
Product Description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for Recall
Kits were labeled with incorrect expiration dates.
Distribution Pattern
The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.
Code Information
Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007