Class II — Meridian Bioscience Inc
| Recalling firm | MERIDIAN BIOSCIENCE, INC. |
|---|---|
| Registered facility | MERIDIAN BIOSCIENCE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay |
| 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. |
| Initiated | 2025-10-07 |
| Classified | 2025-11-19 |
| Recall number | Z-0569-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Meridian Bioscience Inc (Z-0569-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97787/
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