BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.

    Recall: Z-2553-2014 · Reported September 3, 2014

    Enforcement

    Recall Number
    Z-2553-2014
    Event ID
    68854
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 3, 2014
    Initiation Date
    July 16, 2014
    Classification Date
    August 26, 2014
    Termination Date
    December 16, 2014
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.

    Reason

    The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.

    Code Info

    All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338

    Distribution

    Nationwide and internationally, including Canada and Mexico

    Quantity

    2757