BEUDAMED
    FDA Recall Terminated

    ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c

    Recall: Z-1712-2017 · Initiated February 23, 2017

    Recall

    Recall Number
    Z-1712-2017
    Event Number
    76695
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JIS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 23, 2017
    Posted
    March 15, 2017
    Terminated
    May 9, 2018
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c

    Reason

    Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.

    Action

    Siemens mailed an Urgent Medical Device Correction Notice to affected customers on 02/21/2017. The notice informed calibrator customers of the reason for the correction, risk to health, and actions to be taken by customers who are in the process of converting from the fixed factor to the enzyme calibrated assay and information for customers who had already converted, until the investigation is complete.

    Distribution

    Worldwide Distribution - United States Nationwide: Denmark Sweden Norway Great Britain Belgium Netherlands Spain Israel Switzerland France Portugal Greece Germany Slovenia Czech Republic Hong Kong Colombia Korea Australia

    Quantity

    314 calibrators