Meridian Bioscience Inc

Complete recall history across all FDA and CPSC categories — 15 total recalls

Meridian Bioscience Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (15)

FDA medical device enforcement actions by Meridian Bioscience Inc

Date Product Reason Class
Dec 5, 2025 Revogene C. difficile, in vitro diagnostic assay intended for use with the Re... The affected lots show a decline in performance over time, which may lead to ... Class II
Oct 7, 2025 Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Ac... The cap on the reaction buffer tube may be missing the black rubber gasket re... Class II
Oct 7, 2025 Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Ac... The cap on the reaction buffer tube may be missing the black rubber gasket re... Class II
Oct 19, 2023 Para-Pak Clean Vial-For the collection, transportation, preservation, and exa... Plastic vials contain a manufacturing defect may cause an increased risk of l... Class II
Oct 19, 2023 Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, pres... Plastic vials contain a manufacturing defect may cause an increased risk of l... Class II
Oct 19, 2023 Cardinal Health Clean Stool Transportation System-For the collection, transpo... Due to a manufacturing defect, certain Para-Pak vials may be at risk for leak... Class II
Dec 15, 2022 Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative d... Leakage of the original specimen from the plastic microfluidic cartridge (PIE... Class II
Jun 22, 2022 Revogene, Catalog no. 610210. IVD test instrument When a run is aborted, the cooling period protection does not occur and the u... Class II
Feb 15, 2022 Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in c... The photomultiplier tube, may have compromised functionality in some instrume... Class II
Apr 8, 2021 Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalo... Emergency Use Application (EUA) application withdrawn as false negative resul... Class II
Apr 8, 2021 Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Tra... Emergency Use Application (EUA) application withdrawn as false negative resul... Class II
Feb 8, 2021 The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in... Use of the kits after incorrect storage could lead to a potential false-negat... Class II
Dec 17, 2018 PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PR... An enzyme reagent included in the kit is not maintaining stability through cl... Class II
Nov 8, 2016 PREMIER EHEC and PREMIER EHEC Bulk. Internal testing has demonstrated that the indicated kit lots produce false p... Class II
Apr 22, 2014 illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 ... Illumipro-10 instruments may have Block B chambers operating at an incorrect ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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