Z-0731-2022 Class II Ongoing
FDA device recall Z-0731-2022 was initiated by CELLTRION USA INC on Feb 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
- Mar 16, 2022
- Initiation Date
- Feb 25, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0731-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026