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Meridian Bioscience Recalls
15 recalls on record · July 9, 2014 to January 14, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 14, 2026Medical DevicesFDA
Meridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Hazard: The affected lots show a decline in performance over time, which may lead to false-negative results.
November 26, 2025Medical DevicesFDA
Meridian Bioscience Inc recalls Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Hazard: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
November 26, 2025Medical DevicesFDA
Meridian Bioscience Inc recalls Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Hazard: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
December 20, 2023Medical DevicesFDA
Meridian Bioscience Inc recalls Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of s
Hazard: Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
December 20, 2023Medical DevicesFDA
Meridian Bioscience Inc recalls Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimen
Hazard: Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
December 20, 2023Medical DevicesFDA
Meridian Bioscience Inc recalls Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing inte
Hazard: Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
February 1, 2023Medical DevicesFDA
Meridian Bioscience Inc recalls Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Num
Hazard: Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
August 3, 2022Medical DevicesFDA
Meridian Bioscience Inc recalls Revogene, Catalog no. 610210. IVD test instrument
Hazard: When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.
April 6, 2022Medical DevicesFDA
Meridian Bioscience Inc recalls Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Re
Hazard: The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
May 19, 2021Medical DevicesFDA
Meridian Bioscience Inc recalls Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the
Hazard: Emergency Use Application (EUA) application withdrawn as false negative results reported
May 19, 2021Medical DevicesFDA
Meridian Bioscience Inc recalls Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-P
Hazard: Emergency Use Application (EUA) application withdrawn as false negative results reported
March 31, 2021Medical DevicesFDA
Meridian Bioscience Inc recalls The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in
Hazard: Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.
January 23, 2019Medical DevicesFDA
Meridian Bioscience Inc recalls PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoas
Hazard: An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.
January 25, 2017Medical DevicesFDA
Meridian Bioscience Inc recalls PREMIER EHEC and PREMIER EHEC Bulk.
Hazard: Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
July 9, 2014Medical DevicesFDA
Meridian Bioscience Inc recalls illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used wit
Hazard: Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.