BEUDAMED
    FDA Enforcement Class III Terminated

    Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.

    Recall: Z-2175-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2175-2012
    Event ID
    62609
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    July 17, 2012
    Classification Date
    August 9, 2012
    Termination Date
    January 14, 2014
    Address
    500 GBC Drive, Mailstop 514, PO BOX 6101, Newark, DE, 19714-6101, United States

    Description

    Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.

    Reason

    Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. This results in a slope failure and prevents the VANC assay from being run on the Dimension Vista(R) System.

    Code Info

    lot 12095AD, exp 2013-04-04

    Distribution

    Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico.

    Quantity

    1,894 cartons