BEUDAMED
    FDA Recall Terminated

    WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.

    Recall: Z-2125-2015 · Initiated June 3, 2015

    Recall

    Recall Number
    Z-2125-2015
    Event Number
    71380
    Firm
    Perkinelmer
    FEI Number
    3006159931
    Product Code
    JJJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 3, 2015
    Posted
    July 20, 2015
    Terminated
    August 4, 2017
    Address
    940 Winter Street, Waltham, MA, 02451

    Description

    WIZARD2 2-detector, 550 samples Product Code: 2470-0020 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

    Action

    Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to [email protected]

    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

    53 units