FDA-Device2025-11-26Class IIPACKAGING DEFECT
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Hazard
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
109 in total
Manufactured in
3471 River Hills Dr, Cincinnati, OH, United States
Products
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0569-2026Want us to check the next one for you?
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