Celltrion DiaTrust COVID-19 Ag Rapid Test — Class II medical device recall Z-0558-2022
Terminated recall by CELLTRION USA INC, reported 2022-02-09, distributed nationwide. The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was
| Recall number | Z-0558-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CELLTRION USA INC, Jersey City, NJ, United States |
| Recall initiated | 2021-12-01 |
| Classified | 2022-02-03 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2024-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 162,000 units |
| Reason classes | labeling, unapproved product |
| Model numbers | CT-P60, D-2 |
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Reason for recall
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
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-0558-2022. 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.