# FDA recall Z-0504-2022

> **Gentueri Inc** · Class II · device recall initiated 2021-03-18.

## Product

Gentueri Viral Transport Medium (VTM), Sterile, IVD

## Reason for recall

Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.

## Distribution

US Nationwide distribution in the state of Indiana.

## Key facts

- **Recall number:** Z-0504-2022
- **Recalling firm:** Gentueri Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-18
- **Report date:** 2022-01-26
- **Termination date:** 2023-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Verona, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0504-2022

## Citation

> AI Analytics. FDA recall Z-0504-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0504-2022. Source: US FDA. Licensed CC0.

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