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Meridian Bioscience Inc FDA Recalls

12 recalls on file across devices, 0 of them Class I and 9 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300Class IIDec 5, 2025The affected lots show a decline in performance over time, w	The affected lots show a decline in performance over time, which may lead to false-negative results.	Class IIDevices	Dec 5, 2025
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test AssayClass IIOct 7, 2025The cap on the reaction buffer tube may be missing the black	The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leak	Class IIDevices	Oct 7, 2025
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test AssayClass IIOct 7, 2025The cap on the reaction buffer tube may be missing the black	The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leak	Class IIDevices	Oct 7, 2025
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of sClass IIOct 19, 2023Due to a manufacturing defect, certain Para-Pak vials may be	Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.	Class IIDevices	Oct 19, 2023
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing inteClass IIOct 19, 2023Plastic vials contain a manufacturing defect may cause an in	Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of in	Class IIDevices	Oct 19, 2023
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimenClass IIOct 19, 2023Plastic vials contain a manufacturing defect may cause an in	Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of in	Class IIDevices	Oct 19, 2023
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog NumClass IIDec 15, 2022Leakage of the original specimen from the plastic microfluid	Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory pe	Class IIDevices	Dec 15, 2022
Revogene, Catalog no. 610210. IVD test instrumentClass IIJun 22, 2022When a run is aborted, the cooling period protection does no	When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior	Class IIDevices	Jun 22, 2022
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded ReClass IIFeb 15, 2022The photomultiplier tube, may have compromised functionality	The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is lik	Class IIDevices	Feb 15, 2022
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PClass IIApr 8, 2021Emergency Use Application (EUA) application withdrawn as fal	Emergency Use Application (EUA) application withdrawn as false negative results reported	Class IIDevices	Apr 8, 2021
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install theClass IIApr 8, 2021Emergency Use Application (EUA) application withdrawn as fal	Emergency Use Application (EUA) application withdrawn as false negative results reported	Class IIDevices	Apr 8, 2021
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in Class IIFeb 8, 2021Use of the kits after incorrect storage could lead to a pote	Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the eve	Class IIDevices	Feb 8, 2021

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