BEUDAMED
    FDA Enforcement Class II Terminated

    AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.

    Recall: Z-1671-2016 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1671-2016
    Event ID
    73786
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ab Sciex
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 25, 2016
    Initiation Date
    March 25, 2016
    Classification Date
    May 15, 2016
    Termination Date
    May 23, 2016
    Address
    500 Old Connecticut Path, N/A, Framingham, MA, 01701-4574, United States

    Description

    AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.

    Reason

    Under certain conditions, mass spectrometers may report incorrect quantitative results.

    Code Info

    Serial Numbers: Triple Quad 4500MD LC/MS/MS System BX21081601 BX21101601 BX21091601 BX21111601 BX21121602 BX21131602 BX21141602 BX21151602 QTRAP 4500MD LC/MS/MS System BW20251601 BW20241601 BW20261602

    Distribution

    Distributed to the state of NC.

    Quantity

    2 units