BEUDAMED
    FDA Enforcement Class III Terminated

    The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.

    Recall: Z-1216-2017 · Reported February 22, 2017

    Enforcement

    Recall Number
    Z-1216-2017
    Event ID
    76293
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2017
    Initiation Date
    May 5, 2016
    Classification Date
    February 16, 2017
    Termination Date
    February 2, 2018
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.

    Reason

    Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

    Code Info

    Lot Number: 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061

    Distribution

    Distributed throughout the United States

    Quantity

    13,147 units