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Recall Observatory FDA recall evidence

Device product

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

Z-0569-2026

October 07, 2025

Class II

Product summary

Firm
Meridian Bioscience Inc
Event
Event 97787
Status
Ongoing
Classification
Class II
Quantity
109 in total
Official record key
device-enforcement:Z-0569-2026

Official wording

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

Code information: UDI/DI 00840733102196, Lot Numbers: 480350U020, Exp. 2026-06-12

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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