BEUDAMED
    FDA Enforcement Class III Terminated

    Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.

    Recall: Z-0988-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-0988-2013
    Event ID
    63494
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    October 10, 2012
    Classification Date
    March 25, 2013
    Termination Date
    January 8, 2014
    Address
    511 Benedict Avenue, Tarrytown, NY, 10591-5097, United States

    Description

    Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.

    Reason

    Correlation slope bias and accuracy shift

    Code Info

    Lot 2AD052 Catolog KC330

    Distribution

    Nationwide distribution: USA including Puerto Rico and the states of AL, OH, MO, GA, IL, CT, IA, SC, VA, TX, FL, NY, NC, CA, NM, AZ, CA, MI, NJ, PR, MS, NE, WV, PA, MT, MA, MD, KS, NH, TN, VT, LA, CO, ID, WA, NH, DE and OR.

    Quantity

    1985 cartons