BEUDAMED
    FDA Recall 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 · Initiated March 25, 2016

    Recall

    Recall Number
    Z-1671-2016
    Event Number
    73786
    Firm
    Ab Sciex
    FEI Number
    3008935545
    Product Code
    DOP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 25, 2016
    Terminated
    May 23, 2016
    Address
    500 Old Connecticut Path, Framingham, MA, 01701-4574

    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.

    Action

    AB SCIEX issued Urgent: Medical Device Correction letter, dated 3/25/16, advising user of the problem and advising not to use the system until corrected. The letter also discussed the risk to health, as well as how to recognize if the issue has occurred. Sciex Field Service Employee (FSE) will be sent to customer site to perform the field corrective action on the affected system. Questions regarding the letter should be directed to SCIEX at 1-289-982-2531.

    Distribution

    Distributed to the state of NC.

    Quantity

    2 units