# FDA recall Z-0561-2022

> **Gentueri Inc** · Class II · device recall initiated 2020-07-06.

## Product

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

## Reason for recall

Kits failed sterility testing and showed evidence of contamination.

## Distribution

Domestic: Illinois, Nebraska, and Wisconsin.

## Key facts

- **Recall number:** Z-0561-2022
- **Recalling firm:** Gentueri Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-06
- **Report date:** 2022-02-16
- **Termination date:** 2023-12-12

- **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-0561-2022

## Citation

> AI Analytics. FDA recall Z-0561-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0561-2022. Source: US FDA. Licensed CC0.

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