BEUDAMED
    FDA Enforcement Class II 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 · Reported December 5, 2018

    Enforcement

    Recall Number
    Z-0513-2019
    Event ID
    81266
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Health Sciences Canada, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 5, 2018
    Initiation Date
    September 24, 2018
    Classification Date
    November 28, 2018
    Termination Date
    September 17, 2019
    Address
    32 Nixon Rd Unit 1, N/A, Bolton, N/A, N/A, 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.

    Code Info

    210MDBC709100008 210MD8C709140010 210MD8C709150009 210MDBC709160011 210MDBC709180012 210MDBC709200013 210MD8C710020014 210MDBC710050016 210MD8C710110018 210MDBC710170020 210MD8C710180022 210MD8C712220428 210MDBC801240030 210MDBC801250031 210MDBC802140032 210MD8C802150033 210MD8C802260035 210MDBC803190037

    Distribution

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

    Quantity

    18 units