Class II
Medical Device Recall: Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Meridian Bioscience Inc · October 7, 2025
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.
States Affected
AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX, WA
Quantity Affected
109 in total
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0569-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.