BEUDAMED
    FDA Recall Terminated

    AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.

    Recall: Z-2609-2014 · Initiated July 15, 2014

    Recall

    Recall Number
    Z-2609-2014
    Event Number
    68821
    Firm
    Ab Sciex
    FEI Number
    3008935545
    Product Code
    DOP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 15, 2014
    Posted
    September 8, 2014
    Terminated
    October 1, 2014
    Address
    500 Old Connecticut Path, Framingham, MA, 01701-4574

    Description

    AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.

    Reason

    Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis

    Action

    AB SIEX issued letter on 7/15/14, notifying customers to implement this field correction, a temporary fix to be implemented immediately. Additionally, a software update is in development and is expected to be available in approximately 8 weeks. Upon availability, AB SCIEX will send a DVD with instructions on how to install the new software update. At that time, outlined temporary actions will no longer be necessary. If you have any questions regarding this recall, potential hazards or actions to be taken please feel free to contact AB SCI EX at +1 289 982 2531. Please confirm receipt of this letter by signing and faxing back the attached Acknowledgement Form.

    Distribution

    FL, NC, OK, PA, TX

    Quantity

    6 units