Meridian Bioscience Inc recalls Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Recall date

October 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0569-2026

FDA classification

Class II

Brand / firm

Meridian Bioscience Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay