BEUDAMED
    FDA Enforcement Class II Terminated

    Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.

    Recall: Z-2129-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2129-2015
    Event ID
    71380
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Perkinelmer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    June 3, 2015
    Classification Date
    July 20, 2015
    Termination Date
    August 4, 2017
    Address
    940 Winter Street, N/A, Waltham, MA, 02451, United States

    Description

    Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.

    Reason

    Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results

    Code Info

    Serial Numbers: Model: 2470-0200 (13 units DG05129229 DG07118106 DG10129753 SGWZ01150228 SGWZ03140101 SGWZ03150234 SGWZ11140118 SGWZ21130011 SGWZ21130012 SGWZ28130023 SGWZ34140184 SGWZ34140185 SGWZ36130040 Model: 3470-0200 (5 units) DG08129543, DG11129863, SGWZ06150240,SGWZ30130027, SGWZ31130028

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CHINA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ETHIOPIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LUXEMBOURG MEXICO MYANMAR NETHERLANDS NORWAY PHILIPPINES POLAND REUNION SAUDIA ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UK.

    Quantity

    18 units