BEUDAMED
    FDA Recall Terminated

    Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483

    Recall: Z-1799-2018 · Initiated March 12, 2018

    Recall

    Recall Number
    Z-1799-2018
    Event Number
    79699
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    DJG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 12, 2018
    Terminated
    June 2, 2020
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483

    Reason

    Incorrect calibrator level listed in qualitative calibration steps

    Action

    Siemens issued an Urgent Medical Device Correction (UMDC) in the U.S. and an Urgent Field Safety Notification (UFSN) in the OUS on 13-March-2018 to notify Syva Emit II Plus 6-Acetylmorphine customers that the calibrator on the Application Sheet is incorrect.

    Distribution

    PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign