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U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer

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  Class 2 Device Recall Perkin Elmer see related information
Date Initiated by Firm June 03, 2015
Date Posted July 20, 2015
Recall Status1 Terminated 3 on August 04, 2017
Recall Number Z-2124-2015
Recall Event ID 71380
Product Classification Counter (beta, gamma) for clinical use - Product Code JJJ
Product Perkin Elmer WIZARD2 1-detector, 550 samples
Product Code: 2470-0010

The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Code Information Serial Numbers: DG01130080 DG01130128 DG02130139 DG02130158 DG02130178 DG03130208 DG03130232 DG03130261 DG04129163 DG04130302 DG04130313 DG04130333 DG05130345 DG06129271 DG07129377 DG07129415 DG07129440 DG08129500 DG10095598 DG10129695 DG10129757 DG10129798 DG11129811 DG11129855 DG11129869 DG12118732 DG12120022 SGWZ01140092 SGWZ01150226 SGWZ05150239 SGWZ06150241 SGWZ08150247 SGWZ09140113 SGWZ09140114 SGWZ10140116 SGWZ13130003 SGWZ17130006 SGWZ17140135 SGWZ18140139 SGWZ18140140 SGWZ20140147 SGWZ23130016 SGWZ23130017 SGWZ27140164 SGWZ29130025 SGWZ32140179 SGWZ32140180 SGWZ33130034 SGWZ35140190 SGWZ36140192 SGWZ36140193 SGWZ37130043 SGWZ42140204 SGWZ42140207 SGWZ44130058 SGWZ45130063 SGWZ45130065 SGWZ46130068 SGWZ47130075 SGWZ48130077 SGWZ48130078 SGWZ50130087 SGWZ50130088 
Recalling Firm/
Manufacturer
Perkinelmer
940 Winter Street
Waltham MA 02451
For Additional Information Contact Aubrey Doyle
774-278-6455
Manufacturer Reason
for Recall
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
FDA Determined
Cause 2
Nonconforming Material/Component
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 QMresponse.SG@perkinelmer.com
Quantity in Commerce 63 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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