# FDA recall Z-0659-2022

> **CELLTRION USA INC** · Class I · device recall initiated 2021-12-28.

## 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.

## Distribution

US distribution to CA, FL, NJ, NY, PA, SC.

## Key facts

- **Recall number:** Z-0659-2022
- **Recalling firm:** CELLTRION USA INC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-28
- **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-0659-2022

## Citation

> AI Analytics. FDA recall Z-0659-2022. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0659-2022. Source: US FDA. Licensed CC0.

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