# FDA recall Z-0836-2022

> **Meridian Bioscience Inc** · Class II · device recall initiated 2022-02-15.

## Product

Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories.   Meridian branded Revogene: Catalog Number 610210  GenePOC branded Revogene: Catalog Number 130840

## Reason for recall

The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Chile, Italy, Switzerland.

## Key facts

- **Recall number:** Z-0836-2022
- **Recalling firm:** Meridian Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-15
- **Report date:** 2022-04-06

- **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-0836-2022

## Citation

> AI Analytics. FDA recall Z-0836-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0836-2022. Source: US FDA. Licensed CC0.

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