BEUDAMED
    FDA Enforcement Class II Terminated

    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems

    Recall: Z-2062-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2062-2018
    Event ID
    79932
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    March 27, 2018
    Classification Date
    June 4, 2018
    Termination Date
    February 3, 2021
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems

    Reason

    Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.

    Code Info

    Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513

    Distribution

    Nationwide and worldwide

    Quantity

    N/A