Meridian Bioscience — Class II medical device recall Z-0569-2026
Ongoing recall by Meridian Bioscience Inc, reported 2025-11-26, distributed in AL, CO, FL, GA, IL, MD, ME, MT…. The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leak
| Recall number | Z-0569-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meridian Bioscience Inc, Cincinnati, OH, United States |
| Recall initiated | 2025-10-07 |
| Classified | 2025-11-19 |
| Reported by FDA | 2025-11-26 |
| Distributed | AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX, WA |
| Countries outside the US | CA, IT, PA |
| Quantity | 109 in |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00840733102196 |
| Lot numbers | 480350U020 |
| Model numbers | 480050 |
| Expiration dates | 2026-06-12 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0569-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.