BEUDAMED
    FDA Recall Terminated

    PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872

    Recall: Z-0513-2019 · Initiated September 24, 2018

    Recall

    Recall Number
    Z-0513-2019
    Event Number
    81266
    Firm
    PerkinElmer Health Sciences Canada, Inc.
    FEI Number
    3013944243
    Product Code
    DOP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 24, 2018
    Terminated
    September 17, 2019
    Address
    32 Nixon Rd, Unit 1 Bolton Canada

    Description

    PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872

    Reason

    Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotfix 2 software, it is possible for the original data from the last acquired sample to be over-written when the automatic flush is enabled.

    Action

    Perkin Elmer issued notification on 9/24/18 customers are requested to follow instructions contained within the Urgent Medical Device Correction letter and disseminate the information to appropriate functions within their organization. Inform relevant personnel and execute one of the following two options: Qption 1 (Users who do not require Autamatic Flushinq): Deactivate the automatic flushing option in your software: 1) Navigate to the Batch Acquisition Queue tab 2) Click the Queue Options button 3) Under the "System Flush and Standby" section, DESELECT the "Enable automatic flushing" option. Option 2 (Users who require Automatic Flushinqt: Add a non data (blank or "dummy") sample to the acquisition queue to be run as your final sample (before going to Flush/standby). This will ensure that a true sample or control data are not overwritten. Contact PerkinElmer Heatth Scbnces C,arda, Bolton facility Quality Manager- SandiOrdog for further information (647. 505. 8682). The issue identified above will be addressed through a software update. PerkinElmer will contact you when the fix is available and upgrade your software.

    Distribution

    FL, MN, PA India, Italy, Korea, Spain

    Quantity

    18 units