BEUDAMED
    FDA Recall Terminated

    Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.

    Recall: Z-0634-2016 · Initiated December 8, 2015

    Recall

    Recall Number
    Z-0634-2016
    Event Number
    72808
    Firm
    Perkinelmer
    FEI Number
    3006159931
    Product Code
    JJJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 8, 2015
    Posted
    January 12, 2016
    Terminated
    August 4, 2017
    Address
    940 Winter Street, Waltham, MA, 02451

    Description

    Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 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.

    Action

    Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the enclosed Correction Response Form and return it by scan and e-mail to [email protected] . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. For further information contact your local PerkinElmer representatives..

    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

    62 units