Meridian Bioscience Inc
Cincinnati, OH, US
MERIDIAN BIOSCIENCE, INC. appears in FDA device records in Cincinnati, OH. FDA records list 38 510(k) clearances between and , 15 PMA records and one registered establishment. As of , FDA records show 22 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for Meridian Bioscience Inc between 2003 and 2025. The busiest year on record is 2011, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 3 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 4 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243922 | Revogene | OOI | Substantially Equivalent | |
| K230901 | Premier HpSA Flex (619096) | LYR | Substantially Equivalent | |
| K222829 | Curian® Shiga Toxin | GMZ | Substantially Equivalent | |
| K222779 | Revogene | OOI | Substantially Equivalent | |
| K220480 | Revogene | OOI | Substantially Equivalent | |
| K210976 | Curian Campy | LQP | Substantially Equivalent | |
| K192817 | Curian HpSA, Curian Analyzer | LYR | Substantially Equivalent | |
| DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | QDZ | Unknown | |
| K182559 | PREMIER Platinum HpSA PLUS | LYR | Substantially Equivalent | |
| K163273 | TRU Legionella | MJH | Substantially Equivalent | |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | OZX | Substantially Equivalent | |
| K153661 | ImmunoCard STAT! HpSA | LYR | Substantially Equivalent | |
| K152285 | illumigene Pertussis DNA Amplification Assay | OZZ | Substantially Equivalent | |
| K152800 | illumigene Mycoplasma DNA Amplification Assay | OZX | Substantially Equivalent | |
| K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 | PGI | Substantially Equivalent | |
| K133673 | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA | OZZ | Substantially Equivalent | |
| K133714 | TRU FLU | PSZ | Substantially Equivalent | |
| K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT | OZX | Substantially Equivalent | |
| K122019 | STREPTOCOCCUS APP. SEROLOGICAL REAGENTS | OYZ | Substantially Equivalent | |
| K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM | NJR | Substantially Equivalent | |
| K113190 | TRU LEGIONELLA | MJH | Substantially Equivalent | |
| K112048 | IMMUNOCARD C. DIFFICILE GDH | MCB | Substantially Equivalent | |
| K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT | NJR | Substantially Equivalent | |
| K110620 | PREMIER C. DIFFICILE GDH | MCB | Substantially Equivalent | |
| K110012 | ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 | OMN | Substantially Equivalent | |
| K100818 | ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 | OMN | Substantially Equivalent | |
| K092553 | TRU FLU, MODEL 751230 | PSZ | Substantially Equivalent | |
| K090700 | IMMUNOCARD STAT CAMPY, MODEL 751530 | LQP | Substantially Equivalent | |
| K083464 | PREMIER CAMPY, MODEL 618096 | LQP | Substantially Equivalent | |
| K071657 | TRU FLU | PSZ | Substantially Equivalent | |
| K071101 | TRU RSV | GOG | Substantially Equivalent | |
| K062546 | IMMUNOCARD STAT! EHEC, MODEL 751630 | GMZ | Substantially Equivalent | |
| K053335 | PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 | LYR | Substantially Equivalent | |
| K041626 | IMMUNOCARD STAT! FLU A & B | PSZ | Substantially Equivalent | |
| K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 | LLH | Substantially Equivalent | |
| K041445 | IMMUNOCARD STAT! RSV MODEL #750630 | GQG | Substantially Equivalent | |
| K032222 | IMMUNOCARDSTAT HPSA | LYR | Substantially Equivalent | |
| K023599 | IMMUNOCARD STAT! E. COLI O157 PLUS | GMZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1524213 | 1524213 | MERIDIAN BIOSCIENCE, INC. | 3471 River Hills Dr, Cincinnati, OH 45244 US | 2026 | and 41 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MCBAntigen, C. Difficile
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GMIAntigen, Cf And / Or Id, Coccidioides Immitis
- MDUAntigen, Elisa, Cryptococcus
- GMGAntigen, Latex Agglutination, Coccidioides Immitis
- GMZAntigens, All Types, Escherichia Coli
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- GMJAntigens, Histoplasma Capsulatum, All
- GNAAntisera, All Types, Escherichia Coli
- GOGAntisera, Cf, Poliovirus 1-3
- LKIAntisera, Fluorescent, Chlamydia Spp.
- GMDAntisera, Latex Agglutination, Cryptococcus Neoformans
- GQXAntiserum, Cf, Varicella-Zoster
- GMHAntiserum, Positive Control, Coccidioides Immitis
- GMKAntiserum, Positive Control, Histoplasma Capsulatum
- KXGApplicator, Absorbent Tipped, Sterile
- OZZBordetella Pertussis Dna Assay System
- OMNC. Difficile Nucleic Acid Amplification Test Assay
- OZNC. Difficile Toxin Gene Amplification Assay
- LQPCampylobacter Spp.
- KDTContainer, Specimen Mailer And Storage, Sterile
- FMHContainer, Specimen, Sterile
- JSMCulture Media, Non-Propagating Transport
- LKSDevice, Parasite Concentration
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- MIYEnzyme Linked Immunosorbent Assay, Coccidioides Immitis
- LDXFixative, Metallic Containing
- IGGFormaldehyde (Formalin, Formol)
- IFQFormulations, Mercuric Chloride For Tissue
- MHIGiardia Spp.
- OYZGroup A Streptococcus Nucleic Acid Amplification Assay System
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- LYRHelicobacter Pylori
- PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- MJXKit, Serological, Positive Control
- MJHLegionella, Spp., Elisa
- OHQMulti-Analyte Controls Unassayed
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test
- OZXMycoplasma Pneumoniae Dna Assay System
- NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- JZQPlates And Equipment, Radial Immunodiffusion
- LYFPneumocystis Carinii
- QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- LLHReagents, Clostridium Difficile Toxin
- OOIReal Time Nucleic Acid Amplification System
- HYWStain, Trichrome, Mallory'S
- JTSStains, Microbiologic
- PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
- KTNSystem, Test, Infectious Mononucleosis
- OZATest, Urea Adult And Pediatric (Breath),
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1019-2026 | 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. | Class II | Open, Classified | |
| Z-0569-2026 | Meridian Bioscience, Group B Streptococcus, 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. | Class II | Open, Classified | |
| Z-0568-2026 | 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. | Class II | Open, Classified | |
| Z-0521-2024 | Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312 | Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. | Class II | Open, Classified | |
| Z-0520-2024 | Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012 | 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. | Class II | Open, Classified | |
| Z-0519-2024 | Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312 | 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. | Class II | Open, Classified | |
| 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 | 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 | Class II | Open, Classified | |
| Z-1479-2022 | 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 contact with heated instrument components may result in an injury such as minor burns. | Class II | Open, Classified | |
| 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 | 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. | Class II | Open, Classified | |
| Z-1541-2021 | 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 RNA-based assay, and install the Assay Definition File (ADF) file | Emergency Use Application (EUA) application withdrawn as false negative results reported | Class II | Terminated | |
| Z-1540-2021 | 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 from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19 | Emergency Use Application (EUA) application withdrawn as false negative results reported | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| 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 polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF). | 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. | Class II | Terminated | |
| Z-1033-2017 | PREMIER EHEC and PREMIER EHEC Bulk. | Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens. | Class II | Terminated | |
| Z-1941-2014 | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions. | Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration. | Class II | Terminated | |
| Z-0203-2012 | EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4-Substrate II 12.5ml Lot# 1601EXP.5-Stop-Solution II 10.0 ml Lot# 1601EXP.6-EHEC Positive Control 3.4 ml Lot# 8601EXP.7-EHEC Negative Control 3.4 ml Lot# 1603EXP.8-96 transfer pipettes-1 Microwell holder-3 Microwell strip sealers The Premier EHEC test kit is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II ( verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. Coli (EHEC) infections. | Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use. | Terminated | ||
| Z-1203-06 | ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic. | The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates. | Terminated | ||
| Z-0062-04 | Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096. | The kits were packaged with incorrect dispensing pipettes. | Terminated | ||
| Z-1127-03 | Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G. | The Low Positive Standard kit component is losing potency that may result in false positive test results. | Terminated | ||
| Z-0465-03 | Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box. | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. | Terminated | ||
| Z-0464-03 | Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per shipping box. | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. | Terminated | ||
| Z-0463-03 | Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box. | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain