BEUDAMED
    FDA Enforcement Class II Ongoing

    4500MD Triple Quad Mass Spectrometer, Part Number 5032522

    Recall: Z-0038-2024 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-0038-2024
    Event ID
    92810
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AB Sciex, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2023
    Initiation Date
    August 30, 2023
    Classification Date
    October 5, 2023
    Address
    500 Old Connecticut Path, N/A, Framingham, MA, 01701-4574, United States

    Description

    4500MD Triple Quad Mass Spectrometer, Part Number 5032522

    Reason

    In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.

    Code Info

    UDI-DI: 00842365102049; Serial Numbers: EJ230051806PL, EJ230061807PL, EJ230071808, EJ230101810, EJ230111811, EJ230121811, EJ230141811, EJ230151812, EJ230161812, EJ230171901, EJ230181901, EJ230191901, EJ230211905, EJ230221908, EJ230231908, EJ230251909, EJ230271910, EJ230281910, EJ230311911, EJ230331912, EJ230362003, EJ230372003, EJ230392004, EJ230412009, EJ230422011, EJ230442012, EJ230452012, EJ230472101, EJ230482103, EJ230512105, EJ240012110, EJ240022111, EJ240052111, EJ240082207, EJ240092209, EJ240142307, EJ240132305, EJ240062201

    Distribution

    US Nationwide.

    Quantity

    38