BEUDAMED
    FDA Enforcement Class II Terminated

    Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples

    Recall: Z-0636-2016 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0636-2016
    Event ID
    72808
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Perkinelmer
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2016
    Initiation Date
    December 8, 2015
    Classification Date
    January 12, 2016
    Termination Date
    August 4, 2017
    Address
    940 Winter Street, N/A, Waltham, MA, 02451, United States

    Description

    Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples

    Reason

    The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.

    Code Info

    Serial Numbers: DG04129084 DG12118776 DG04117773 DG05106408

    Distribution

    Worldwide Distribution - US Nationwide and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.

    Quantity

    4 units