BEUDAMED
    FDA Recall Open, Classified

    Citrine QTRAP Mass Spectrometer, Part Number 5063685

    Recall: Z-0039-2024 · Initiated August 30, 2023

    Recall

    Recall Number
    Z-0039-2024
    Event Number
    92810
    Firm
    AB Sciex, LLC
    FEI Number
    3008935545
    Product Code
    DOP
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    August 30, 2023
    Posted
    October 5, 2023
    Address
    500 Old Connecticut Path, Framingham, MA, 01701-4574

    Description

    Citrine QTRAP Mass Spectrometer, Part Number 5063685

    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.

    Action

    An URGENT: RUO and MEDICAL DEVICE FIELD ACTION notification letter dated 7/20/23 was sent to customers. Actions to be taken by the Customer/User: SCIEX will provide a replacement nut for eligible sources and systems. Instructions will be provided to guide you through the replacement of the nut. The replacement parts with installation instructions are estimated to begin shipping in October 2023. SCIEX is currently notifying affected customers of the upcoming countermeasure. Upon availability, SCIEX will send you the replacement nut with instructions on how to install it on the ion source probe. We sincerely apologize for any inconvenience that this may cause you. SCIEX aims to provide you with products of the highest quality. If you have any questions regarding this notice, please contact https://sciex.com/aboutus/ contact-us or https://sciex.com/support/request-support.

    Distribution

    US Nationwide.

    Quantity

    10