FDA recall record · openFDA

Meridian Bioscience Inc

6 FDA recalls on record (2023–2025) — 6 device. 6 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and re 2

Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental e 2

Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. 1

The affected lots show a decline in performance over time, which may lead to false-negative results. 1

Recalls

Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay Class II 2025-10-07 Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay Class II 2025-10-07 Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 Class II 2025-12-05 Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of s Class II 2023-10-19 Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimen Class II 2023-10-19 Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing inte Class II 2023-10-19

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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