Celltrion DiaTrust COVID-19 Ag Rapid Test — Class II medical device recall Z-0731-2022
Ongoing recall by CELLTRION USA INC, reported 2022-03-16, distributed in CA, CT, FL, HI, MA, MT, NJ, NY…. Kits were labeled with incorrect expiration dates.
| Recall number | Z-0731-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CELLTRION USA INC, Jersey City, NJ, United States |
| Recall initiated | 2022-02-25 |
| Classified | 2022-03-08 |
| Reported by FDA | 2022-03-16 |
| Distributed | CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, TX |
| Quantity | 1,228,200 tests |
| Reason classes | labeling |
| Lot numbers | COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007 |
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for recall
Kits were labeled with incorrect expiration dates.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0731-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.