The Recall Desk

Manufacturer

Meridian Bioscience Inc

15 recalls in our database name Meridian Bioscience Inc as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
0
Severe
2
Most recent
2026-01-14

Of the 15 recalls from Meridian Bioscience Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (13%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–15 of 15

  • HighFDA (Devices)·Z-1019-2026·2026-01-14

    C. difficile assay recalled over declining performance and false negative results

    Meridian Bioscience is recalling 211 units of the Revogene C. difficile assay because affected lots show a decline in performance over time, which may lead to false-negative results.

    Product
    Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2026·2025-11-26

    Group B strep test kits recalled over buffer caps missing gaskets

    Meridian Bioscience is recalling Group B Streptococcus nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.

    Product
    Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0568-2026·2025-11-26

    C difficile test kits recalled over buffer caps missing a gasket

    Meridian Bioscience is recalling alethia C. difficile nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.

    Product
    Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0521-2024·2023-12-20

    Cardinal Health Stool Transportation System Recalled for Vial Leakage

    Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.

    Product
    Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2024·2023-12-20

    Medical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk

    Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.

    Product
    Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2024·2023-12-20

    Para-Pak Clean Vial Stool Collection Kits Recalled for Manufacturing Defect

    Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.

    Product
    Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2023·2023-02-01

    COVID-19 diagnostic test kits recalled for specimen leakage risk

    Meridian Bioscience is recalling 92 Revogene SARS-CoV-2 test kits due to potential specimen leakage from the cartridge, which could expose laboratory personnel to aerosolized COVID-19 virus.

    Product
    Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2022·2022-08-03

    Revogene diagnostic test instrument recalled for burn risk from cooling failure

    Meridian Bioscience recalled 459 Revogene diagnostic instruments due to a cooling protection failure that may expose users to heated components, risking minor burn injuries.

    Product
    Revogene, Catalog no. 610210. IVD test instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2022·2022-04-06

    Revogene diagnostic device recalled for photomultiplier tube malfunction

    Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1540-2021·2021-05-19

    Meridian Revogene SARS-CoV-2 Test Recalled Due to False Negative Results

    Meridian Bioscience is recalling 376 Revogene SARS-CoV-2 test kits because the FDA withdrew the Emergency Use Application after false negative results were reported.

    Product
    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 susp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2021·2021-05-19

    Meridian Revogene RNA Software Upgrade Kits Recalled Due to False Negatives

    Meridian Bioscience is recalling 124 Revogene RNA Software Upgrade Kits because the FDA withdrew the Emergency Use Application after false negative results were reported.

    Product
    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) f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2021·2021-03-31

    Meridian ImmunoCard Mycoplasma EIA Recalled for Potential False-Negative Results

    Meridian Bioscience is recalling 8 ImmunoCard Mycoplasma EIA kits due to incorrect storage that could cause false-negative or invalid results, potentially delaying appropriate patient treatment.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2019·2019-01-23

    Meridian Premier Cryptococcal Antigen Test Recalled for Stability Issues

    Meridian Bioscience is recalling Premier Cryptococcal Antigen kits because an enzyme reagent may not maintain stability, potentially causing false negative results.

    Product
    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 cerebr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2017·2017-01-25

    Meridian Premier EHEC Diagnostic Kits Recalled for False Positive Results

    Meridian Bioscience is recalling Premier EHEC and Premier EHEC Bulk diagnostic kits because internal testing showed they can produce false positive results with some broth specimens.

    Product
    PREMIER EHEC and PREMIER EHEC Bulk.
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-1941-2014·2014-07-09

    Meridian Bioscience Recalls illumipro-10 Incubator/Reader Units for Calibration Issues

    Meridian Bioscience is recalling 35 illumipro-10 incubator/reader units because Block B chambers may operate at incorrect temperatures due to calibration errors.

    Product
    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.
    Category
    Medical Device
    Distribution
    17 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Meridian Bioscience

company in Cincinnati, United States

Country
United States
Founded
1977

Source: Wikidata (Q17113726), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.