BEUDAMED
    FDA Recall Terminated

    Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System

    Recall: Z-1433-2012 · Initiated February 17, 2012

    Recall

    Recall Number
    Z-1433-2012
    Event Number
    61465
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JGJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 17, 2012
    Posted
    April 17, 2012
    Terminated
    March 10, 2015
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System

    Reason

    Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium

    Action

    Siemens sent an Urgent Field Safety Notification letter dated February 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter explained the correction needed and instructed customers to forward the letter to anyone they may have distributed the affected product. For questions or concerns call 800-441--9250. For questions regarding this recall call 301-631-6299.

    Distribution

    Nationwide Distribution including Puerto Rico and within the US to Washington, DC and the following States: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.

    Quantity

    9,178