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