Cincinnati, OH, United States
Meridian Bioscience Inc recalls
9 recalls recorded since 2018, most recently on 5 December 2025. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)6
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 December 2025
- Reason
- The affected lots show a decline in performance over time, which may lead to false-negative results.
- Distribution
- US Nationwide distribution and the OUS country of Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1019-2026
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Ongoing Class II Medical devices
- Recall started
- 7 October 2025
- Reason
- The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
- Distribution
- US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0568-2026, Z-0569-2026
- Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
- Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Ongoing Class II Medical devices
- Recall started
- 19 October 2023
- Reason
- Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
- Distribution
- Nationwide Foreign: Italy
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0521-2024, Z-0520-2024, Z-0519-2024
- Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
- Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
- Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Ongoing Class II Medical devices
- Recall started
- 15 December 2022
- Reason
- 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
- Distribution
- US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1008-2023
- Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Ongoing Class II Medical devices
- Recall started
- 22 June 2022
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1479-2022
- Revogene, Catalog no. 610210. IVD test instrument
Ongoing Class II Medical devices
- Recall started
- 15 February 2022
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Chile, Italy, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0836-2022
- Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
Terminated Class II Medical devices
- Recall started
- 8 April 2021
- Terminated
- 26 October 2021
- Reason
- Emergency Use Application (EUA) application withdrawn as false negative results reported
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1540-2021, Z-1541-2021
- Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid fr
- Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RN
Terminated Class II Medical devices
- Recall started
- 8 February 2021
- Terminated
- 26 October 2021
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of OH, SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1299-2021
- The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
Terminated Class II Medical devices
- Recall started
- 17 December 2018
- Terminated
- 30 April 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AK, CA, CO, DE, IL, KS, KY, LA, MD, MO, NC, ND, NJ, NY, SC, TX, and VA. The products were distributed to the following foreign countries: India and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0732-2019
- PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccha
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.