Meridian Bioscience recalls
7 official recalls and safety alerts involving Meridian Bioscience since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Meridian Bioscience or the relevant agency.
- 2026-01-14
USMeridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
The affected lots show a decline in performance over time, which may lead to false-negative results.
FDA · DeviceMeridian Bioscience IncUS Nationwide distribution and the OUS country of Italy.Official notice →- 2025-11-26
- US
Meridian Bioscience Inc recalls Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
FDA · DeviceMeridian Bioscience IncUS Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN,…Official notice → - 2023-12-20
- US
Meridian Bioscience Inc recalls Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens…
Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
- US
Meridian Bioscience Inc recalls Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal…
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.
- 2023-02-01
- US
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 Number: 410700
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
FDA · DeviceMeridian Bioscience IncUS Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN,…Official notice → - 2022-08-03
- US
Meridian Bioscience Inc recalls Revogene, Catalog no. 610210. IVD test instrument
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…
FDA · DeviceMeridian Bioscience IncWorldwide distribution - US Nationwide and the countries of Australia, Chile,…Official notice → - 2022-04-06
- US
Meridian Bioscience Inc recalls Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog…
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.
FDA · DeviceMeridian Bioscience IncWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →