Recall archive / FDA device enforcement
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 — FDA record Z-0680-2022
Reported terminated
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 Dec 2, 2021. 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
- Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
- Classification
- Class I
- Recalling firm
- CELLTRION USA INC
- Quantity
- 8080 kits originally distributed; 726 kits redistributed
- Agency-reported status
- Terminated
- Source record identifier
- Z-0680-2022
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 | Lots COVGCCF0001, COVGCCF0002 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed to 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 9, 2022
- Recall initiation date
- Dec 2, 2021
- Center classification date
- Mar 2, 2022
- Termination date
- Jun 10, 2024
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.