Celltrion DiaTrust COVID-19 Ag Rapid Test — Class I medical device recall Z-0659-2022
Terminated recall by CELLTRION USA INC, reported 2022-03-09, distributed in CA, FL, NJ, NY, PA, SC. The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, b
| Recall number | Z-0659-2022 |
|---|---|
| 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 | 2021-12-28 |
| Classified | 2022-03-02 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2024-06-10 |
| Distributed | CA, FL, NJ, NY, PA, SC |
| Lot numbers | COVGCCM0008 |
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for recall
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.
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-0659-2022. 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.