Meridian Bioscience recalls
Meridian Bioscience appears in 15 official U.S. recall notices indexed by RecallRadar, most recently on 2026-01-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 15 |
|---|---|
| Published | 2014-07-09 to 2026-01-14 |
| By agency | FDA Device (15) |
| By classification | Class II (15) |
| By status | ongoing (9), terminated (6) |
| Distribution named in notices | AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
FDA Device · Class II · 2026-01-14 · Meridian Bioscience
Reason: The affected lots show a decline in performance over time, which may lead to false-negative results. - Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Device · Class II · 2025-11-26 · Meridian Bioscience
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. - Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
FDA Device · Class II · 2025-11-26 · Meridian Bioscience
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. - Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal pa…
FDA Device · Class II · 2023-12-20 · Meridian Bioscience
Reason: 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. - Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Ca…
FDA Device · Class II · 2023-12-20 · Meridian Bioscience
Reason: 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. - Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens cont…
FDA Device · Class II · 2023-12-20 · Meridian Bioscience
Reason: Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. - Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
FDA Device · Class II · 2023-02-01 · Meridian Bioscience
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 - Revogene, Catalog no. 610210
FDA Device · Class II · 2022-08-03 · Meridian Bioscience
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 conta… - Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories
FDA Device · Class II · 2022-04-06 · Meridian Bioscience
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. - Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Softwar…
FDA Device · Class II · 2021-05-19 · Meridian Bioscience
Reason: Emergency Use Application (EUA) application withdrawn as false negative results reported - Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run…
FDA Device · Class II · 2021-05-19 · Meridian Bioscience
Reason: Emergency Use Application (EUA) application withdrawn as false negative results reported - The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of re…
FDA Device · Class II · 2021-03-31 · Meridian Bioscience
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 appro… - PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening…
FDA Device · Class II · 2019-01-23 · Meridian Bioscience
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. - PREMIER EHEC and PREMIER EHEC Bulk
FDA Device · Class II · 2017-01-25 · Meridian Bioscience
Reason: Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. - illumipro-10 Incubator/Reader, Meridian Bioscience, Inc
FDA Device · Class II · 2014-07-09 · Meridian Bioscience
Reason: Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.