BEUDAMED
    FDA Enforcement Class II Ongoing

    HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

    Recall: Z-2166-2024 · Reported July 10, 2024

    Enforcement

    Recall Number
    Z-2166-2024
    Event ID
    94839
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Horiba Instruments Incorporated
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    July 10, 2024
    Initiation Date
    March 28, 2024
    Classification Date
    July 1, 2024
    Address
    20 Knightsbridge Rd, N/A, Piscataway, NJ, 08854-3913, United States

    Description

    HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

    Reason

    HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light source and the excitation monochromator. A plastic cap was installed to plug the optical port, where a more durable beam stop should have been used. The defect may allow the class 4 laser beam to burn (or transmit) through the plastic cap to exit the protective enclosure.

    Code Info

    Modular Fluorolog-QM

    Distribution

    US Nationwide and Worldwide Distribution

    Quantity

    4 units