# FDA recall Z-0558-2022

> **CELLTRION USA INC** · Class II · device recall initiated 2021-12-01.

## 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.

## Distribution

US Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-0558-2022
- **Recalling firm:** CELLTRION USA INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-01
- **Report date:** 2022-02-09
- **Termination date:** 2024-06-17

- **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-0558-2022

## Citation

> AI Analytics. FDA recall Z-0558-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0558-2022. Source: US FDA. Licensed CC0.

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