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Recall Observatory FDA recall evidence

Device product

Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.

Z-2128-2015

June 03, 2015

Class II

Product summary

Firm
Perkinelmer
Event
Event 71380
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-2128-2015

Official wording

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

Code information: Serial Numbers: Model: 2470-0150 (1 unit): SGWZ36130042 Model: 3470-0150 (1 unit): SGWZ19140141

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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