Recall archive / FDA device enforcement
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 — FDA record Z-0731-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Reason
- Kits were labeled with incorrect expiration dates.
- Classification
- Class II
- Recalling firm
- CELLTRION USA INC
- Quantity
- 1,228,200 tests
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0731-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 16, 2022
- Recall initiation date
- Feb 25, 2022
- Center classification date
- Mar 8, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.