BEUDAMED
    FDA Enforcement Class II Ongoing

    API3200MD Mass Spectrometer, Part Number 4466230

    Recall: Z-0037-2024 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-0037-2024
    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

    API3200MD Mass Spectrometer, Part Number 4466230

    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

    Serial Numbers: EQ230011907, EQ230021911, EQ230001901

    Distribution

    US Nationwide.

    Quantity

    3