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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 Elmersee related information
Date Initiated by FirmDecember 08, 2015
Date PostedJanuary 12, 2016
Recall Status1 Terminated 3 on August 04, 2017
Recall NumberZ-0633-2016
Recall Event ID 72808
Product Classification Counter (beta, gamma) for clinical use - Product Code JJJ
ProductPerkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Code Information Serial Numbers: DG02117524 DG09118363 DG08118156 DG08118195 DG02128922 DG10118375 DG12107235 DG08118222 DG02117537 DG08118184 DG09106872 DG11107116 DG03117626 DG03117611 DG01117425 DG12107293 DG09118332 DG06106503 DG06118006 DG01128820 DG12118707 DG05106427 DG03106166 DG11118630 DG01117434 DG09106779 DG02117500 DG12118742 DG06106477 DG03106208 DG09106800 DG10106903 DG05117853 DG03117671 DG06106473 DG04117754 DG04117698 DG11118538 DG11118617 DG01117392 DG03117644 DG05117882 DG03117655 DG04117683 DG02106106 DG05106347 DG06118043 DG10118385 DG08106671 DG01128869 DG06118023 DG05106328 DG02117516 DG11107142 DG05106354 DG08118254 DG03106181 DG03106197 DG02117505 DG11107105 
FEI Number 3006159931
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
ActionPerkin 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 Commerce60 units
DistributionWorldwide 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 CycleTPLC 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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