# FDA recall Z-1019-2026

> **Meridian Bioscience Inc** · Class II · device recall initiated 2025-12-05.

## Product

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

## Reason for recall

The affected lots show a decline in performance over time, which may lead to false-negative results.

## Distribution

US Nationwide distribution and the OUS country of Italy.

## Key facts

- **Recall number:** Z-1019-2026
- **Recalling firm:** Meridian Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-05
- **Report date:** 2026-01-14

- **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-1019-2026

## Citation

> AI Analytics. FDA recall Z-1019-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1019-2026. Source: US FDA. Licensed CC0.

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