BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOGENE

    MDR report key: 23658911 · Received November 26, 2025

    Report

    Report Number
    1524213-2025-00005
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 26, 2025
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    UDI-DI
    00840733102318
    PMA / PMN Number
    K243922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON NOVEMBER 3, 2025, MERIDIAN BIOSCIENCE INC. TECHNICAL SERVICE DEPARTMENT RECEIVED A CALL FROM A CUSTOMER WHO REPORTED ABORTING A RUN AFTER HEARING A LOUD NOISE AND SMELLING A BURNING SMELL. THE CUSTOMER DID NOT SEE ANY SMOKE OR FEEL ANY HEAT, AND NO ONE WAS INJURED. WHILE THERE WERE NO REPORTED CLAIMS OF SERIOUS INJURY OR HARM WERE REPORTED, MERIDIAN HAS ELECTED TO SUBMIT THIS REPORT OUT OF AN EXTREME ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620462 REVOGENE REVOGENE OOI MERIDIAN BIOSCIENCE INC. 00840733102318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown