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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 December 08, 2015
Date Posted January 12, 2016
Recall Status1 Terminated 3 on August 04, 2017
Recall Number Z-0637-2016
Recall Event ID 72808
Product Classification Counter (beta, gamma) for clinical use - Product Code JJJ
Product Perkin Elmer WIZARD2 10-detector, 1000 samples.
Product Code: 2470-0200, 3470-0200.
The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Code Information Serial Numbes: DG08118243 DG12118732 DG09106871 DG03117554 DG05106373 DG02117481 DG11107153 DG07118106 DG03128981 DG04106316 DG03117574 DG04106296 DG04117674 DG05106414 DG02117455 DG07106607 DG11107048 DG03106163 DG07106604 DG05117805 DG08106759 DG03129008 
Recalling Firm/
Manufacturer		 Perkinelmer
940 Winter Street
Waltham MA 02451
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the enclosed Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. For further information contact your local PerkinElmer representatives..
Quantity in Commerce 22 units
Distribution 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.
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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