# FDA recall Z-0731-2022

> **CELLTRION USA INC** · Class II · device recall initiated 2022-02-25.

## Product

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

## Reason for recall

Kits were labeled with incorrect expiration dates.

## Distribution

The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.

## Key facts

- **Recall number:** Z-0731-2022
- **Recalling firm:** CELLTRION USA INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-25
- **Report date:** 2022-03-16

- **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-0731-2022

## Citation

> AI Analytics. FDA recall Z-0731-2022. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0731-2022. Source: US FDA. Licensed CC0.

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