BEUDAMED
    FDA Enforcement Class II Terminated

    ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

    Recall: Z-1658-2014 · Reported June 4, 2014

    Enforcement

    Recall Number
    Z-1658-2014
    Event ID
    67953
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 4, 2014
    Initiation Date
    April 10, 2014
    Classification Date
    May 23, 2014
    Termination Date
    May 27, 2016
    Address
    333 Coney St, East Walpole, MA, 02032-1516, United States

    Description

    ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

    Reason

    Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.

    Code Info

    Kit lots ending in/Exp Date: 050 08 August 2014 051 20 September 2014 052 11 December 2014 053 10 December 2014 054 07 March 2015

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.

    Quantity

    40,266 kits