Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Reported: November 26, 2025 Initiated: October 7, 2025 #Z-0569-2026
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.
Details
- Recalling Firm
- Meridian Bioscience Inc
- Units Affected
- 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.
- Location
- Cincinnati, OH
Frequently Asked Questions
What product was recalled? ▼
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay. Recalled by Meridian Bioscience Inc. Units affected: 109 in total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0569-2026.
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