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Recall Observatory FDA recall evidence

Device product

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

Z-0636-2016

December 08, 2015

Class II

Product summary

Firm
Perkinelmer
Event
Event 72808
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-0636-2016

Official wording

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 information: Serial Numbers: DG04129084 DG12118776 DG04117773 DG05106408

Distribution pattern: 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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label in the Barcode ID Label Binder is incorrect