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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-2127-2015
Recall Event ID 71380
Product Classification Counter (beta, gamma) for clinical use - Product Code JJJ
Product Perkin Elmer WIZARD2 10-detector, 550 samples
Product Code: 2470-0100, 3470-0100

The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Code Information Serial Numbers: Model: 2470-0100 (51 units) DG01130134 DG02130152 DG03130216 DG03130255 DG04130263 DG04130279 DG04130289 DG04130328 DG05129261 DG06106456 DG06129310 DG08129556 DG10129701 DG10129780 DG11129850 DG11129872 DG12118702 DG12120031 DG12129891 SGWZ02140093 SGWZ02140094 SGWZ03140098 SGWZ03140099 SGWZ03140100 SGWZ05140104 SGWZ06150243 SGWZ07150244 SGWZ09150248 SGWZ10150252 SGWZ11150255 SGWZ12130001 SGWZ16140132 SGWZ17140137 SGWZ19140144 SGWZ20140148 SGWZ21130009 SGWZ21140151 SGWZ24130019 SGWZ27130021 SGWZ27140166 SGWZ29140171 SGWZ31140175 SGWZ34130035 SGWZ36130038 SGWZ37140196 SGWZ45130061 SGWZ45130067 SGWZ48140219 SGWZ49140222 SGWZ50130086 SGWZ52130091  Model: 3470-0100 (3 units)  DG11129817, SGWZ21130010,SGWZ27140163   
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 54 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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