BEUDAMED
    FDA Enforcement Class II 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 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2609-2014
    Event ID
    68821
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ab Sciex
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2014
    Initiation Date
    July 15, 2014
    Classification Date
    September 8, 2014
    Termination Date
    October 1, 2014
    Address
    500 Old Connecticut Path, N/A, Framingham, MA, 01701-4574, United States

    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

    Code Info

    Serial Numbers: BV20031308, BV20081311, BV20051310, BV20071311, BV20101401, BV20131401

    Distribution

    FL, NC, OK, PA, TX

    Quantity

    6 units