# FDA recall Z-0953-2022

> **CELLTRION USA INC** · Class I · device recall initiated 2022-04-01.

## Product

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

## Reason for recall

Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0953-2022
- **Recalling firm:** CELLTRION USA INC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-01
- **Report date:** 2022-05-04
- **Termination date:** 2024-06-11

- **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-0953-2022

## Citation

> AI Analytics. FDA recall Z-0953-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0953-2022. Source: US FDA. Licensed CC0.

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