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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-0632-2016
Recall Event ID 72808
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: DG06106539 DG12118720 DG07106646 DG12107250 DG12107281 DG03117619 DG11118605 DG01117400 DG12107202 DG01117401 DG06106449 DG03117666 DG05117791 DG06106454 DG03106180 DG11118637 DG07118121 DG07106598 DG11118633 DG06106520 DG03106137 DG07118111 DG02128888 DG08118247 DG06118014 DG01128790 DG12107207 DG07106637 DG01128876 DG04117764 DG01106035 DG12118780 DG05106342 DG01117399 DG06117909 DG06118011 DG09106846 DG11107146 DG12118694 DG08118217 DG02106084 DG04117690 DG05117838 DG09106799 DG04117735 DG03117548 DG01117362 
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 47 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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