# FDA recall Z-1008-2023

> **Meridian Bioscience Inc** · Class II · device recall initiated 2022-12-15.

## Product

Revogene SARS-CoV-2_IVD real-time RT-PCR test  intended for the qualitative detection of RNA from SARSCoV-2  Catalog Number: 410700

## Reason for recall

Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2

## Distribution

US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.

## Key facts

- **Recall number:** Z-1008-2023
- **Recalling firm:** Meridian Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-15
- **Report date:** 2023-02-01

- **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-1008-2023

## Citation

> AI Analytics. FDA recall Z-1008-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1008-2023. Source: US FDA. Licensed CC0.

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