Recall archive / FDA device enforcement
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 — FDA record Z-0659-2022
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 28, 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
- The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
- Classification
- Class I
- Recalling firm
- CELLTRION USA INC
- Quantity
- 243 kits (6,075 tests)
- Agency-reported status
- Terminated
- Source record identifier
- Z-0659-2022
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 COVGCCM0008 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to CA, FL, NJ, NY, PA, SC.
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 28, 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.