Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Tes...
FDA Recall #Z-0569-2026 — Class II — October 7, 2025
Product Description
Meridian Bioscience, Group B Streptococcus, 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.
Recalling Firm
Meridian Bioscience Inc — Cincinnati, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
109 in total
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.
Code Information
UDI/DI 00840733102196, Lot Numbers: 480350U020, Exp. 2026-06-12
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated