BEUDAMED
    FDA Recall 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 · Initiated July 17, 2012

    Recall

    Recall Number
    Z-2175-2012
    Event Number
    62609
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    LEH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 17, 2012
    Posted
    August 9, 2012
    Terminated
    January 14, 2014
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    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.

    Action

    The firm initiated their recall of this product on July 17, 2012 by sending an Urgent Field Safety Notification via FedEx next day delivery to all consignees. The Notice informed consignees of the high calibration slopes with the affected device. Affected consignees were requested to immediately discontinue use and discard any remaining Dimension Vista(R) VANC Flex(R) reagent cartridges, lot 12095AD. Affected customers were provided with replacement cartridges. Customers were to also complete the attached form and fax it back to the number provided. The notification letter should be forwarded to anyone, whom customers may have further distributed the affected lot. Questions and concerns should be directed to Siemens Technical Solutions Center at 800-441-9250.

    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