# FDA recall Z-0680-2022

> **CELLTRION USA INC** · Class I · device recall initiated 2021-12-02.

## 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.

## Distribution

Distributed to TX.

## Key facts

- **Recall number:** Z-0680-2022
- **Recalling firm:** CELLTRION USA INC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-02
- **Report date:** 2022-03-09
- **Termination date:** 2024-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jersey City, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0680-2022

## Citation

> AI Analytics. FDA recall Z-0680-2022. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0680-2022. Source: US FDA. Licensed CC0.

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