BEUDAMED
    FDA Enforcement Class III Terminated

    Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.

    Recall: Z-1048-2013 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1048-2013
    Event ID
    64570
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2013
    Initiation Date
    February 27, 2013
    Classification Date
    April 1, 2013
    Termination Date
    January 14, 2014
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.

    Reason

    Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h

    Code Info

    Siemens Material Number 10636929

    Distribution

    Worldwide Distribution.

    Quantity

    2207 total