Celltrion DiaTrust COVID-19 Ag Rapid Test — Class I medical device recall Z-0953-2022
Terminated recall by CELLTRION USA INC, reported 2022-05-04, distributed nationwide. Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
| Recall number | Z-0953-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CELLTRION USA INC, Jersey City, NJ, United States |
| Recall initiated | 2022-04-01 |
| Classified | 2022-04-27 |
| Reported by FDA | 2022-05-04 |
| Terminated | 2024-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 12,632 kits |
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for recall
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
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-0953-2022. 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.