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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-0634-2016
Recall Event ID 72808
Product Classification Counter (beta, gamma) for clinical use - Product Code JJJ
Product Perkin Elmer ClWIZARD2 5-detector, 550 samples
Product Code: 2470-0050, 3470-0050.
The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Code Information Model: 2470-0050 Serial Numbers: DG05106329 DG02117493 DG11107166 DG09106782 DG07118133 DG07118141 DG09106791 DG04117727 DG06118036 DG12107192 DG02106101 DG04106223 DG01128843 DG12107272 DG07118124 DG09106892 DG12118684 DG12118673 DG11107126 DG04117704 DG04117763 DG01117363 DG06106484 DG12107240 DG01128871 DG05117880 DG12118685 DG09118357 DG03106204 DG05106386 DG11107137 DG03106172 DG03106206 DG02106113 DG09106818 DG02106065 DG04106309 DG09106882 DG11118590 DG06106483 DG01117316 DG08118221 DG06117898 DG12107263 DG08118250 DG12118711 DG04117710 DG06106448 DG06106453 DG06106463 DG06117912 DG03106135 DG01117373 DG05117837 DG06106517 DG01128805 DG06117970 DG04106310 DG02117521 DG06106538 Model: 3470-0050 (2 units) Serial Numbers: DG12118660 DG10118464 
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 62 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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