Celltrion DiaTrust COVID-19 Ag Rapid Test — Class I medical device recall Z-0680-2022
Terminated recall by CELLTRION USA INC, reported 2022-03-09, distributed in TX. Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). A
| Recall number | Z-0680-2022 |
|---|---|
| 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 | 2021-12-02 |
| Classified | 2022-03-02 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2024-06-10 |
| Distributed | TX |
| Lot numbers | COVGCCF0001, COVGCCF0002 |
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for recall
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.
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-0680-2022. 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.