# FDA recall Z-0568-2026

> **Meridian Bioscience Inc** · Class II · device recall initiated 2025-10-07.

## Product

Meridian Bioscience, alethia  c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

## Reason for recall

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

## Distribution

US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.

## Key facts

- **Recall number:** Z-0568-2026
- **Recalling firm:** Meridian Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-07
- **Report date:** 2025-11-26

- **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-0568-2026

## Citation

> AI Analytics. FDA recall Z-0568-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0568-2026. Source: US FDA. Licensed CC0.

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