# FDA recall Z-1479-2022

> **Meridian Bioscience Inc** · Class II · device recall initiated 2022-06-22.

## Product

Revogene, Catalog no. 610210.  IVD test instrument

## Reason for recall

When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.

## Key facts

- **Recall number:** Z-1479-2022
- **Recalling firm:** Meridian Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-22
- **Report date:** 2022-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cincinnati, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2022

## Citation

> AI Analytics. FDA recall Z-1479-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1479-2022. Source: US FDA. Licensed CC0.

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