FDA recall Z-0568-2026

Meridian Bioscience Inc · Class II · device

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

Status
Ongoing
Initiation date
2025-10-07
Report date
2025-11-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0568-2026