Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-0638-2016
Recall Event ID 72808
Product Classification Counter (beta, gamma) for clinical use - Product Code JJJ
Product Perkin Elmer WIZARD2 1-detector,3", 1000 samples.
Product Code: 2480-0010
The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
Code Information Serial Numbers: DG12107256 DG04106256 DG08118161 DG03117633 DG09118348 DG06117938 DG04106271 DG03117625 DG11118603 DG03129003 DG11107087 DG09118269 DG09118346 DG09118323 DG09118410 DG10118462 DG12118695 DG03129030 DG05117802 DG04129089 DG11107086 DG03117631 DG10118453 DG01117421 DG04106256_REWORK DG06106456 DG03106146 DG11118564 DG03129000 DG02106095 DG08106711 DG02128912 DG10106940 DG07118046 DG07118051 DG03117635 DG09118273 DG05117890 DG12118657 DG09118349 DG03117557 DG10118483 DG10118478 DG11107160 DG04129156 DG02106081 DG09118167 DG02128958 DG03129032 DG03117634 DG11118575 DG08118256 DG05106334 DG10106910 DG10106950 DG03117630 DG05106409 DG07106656 DG12107176 DG05106333 DG05117810 DG10106978 DG03106122 DG12107186 DG08106662 DG05117817 DG05117874 DG02128962 DG11118610 DG03129033 DG03129034 DG12118735 DG11107053 DG09118307 DG07118070 DG09118306 DG08118170 DG02128953 DG02128936 DG03129053 DG08118162 DG11118587 DG03129031 DG02128933 DG03129002 DG03129001 DG08118163 DG02128895 DG10118489 DG02117474 DG09118281 DG09118316 DG10106976 DG06117966 DG06106504 DG08118168 DG08118169 DG11118545 DG01128861 DG10118448 DG10118458 DG10118474 DG10118458 DG10118472 DG01128794 DG03129055 DG09118321 DG07118071 DG10118440 DG02128879 DG03117632 DG10118408 DG02128927 DG06106505 DG10118418 DG01128802 DG12118717 DG12118769 DG12118783 DG01106026 DG09106876 DG03129068 DG05106332 DG01105987 DG03106128 DG10118388 DG08118165 DG01128850 DG06117937 DG06117936 DG06117939 DG08118166 DG04117759 DG11118579 DG10118424 DG01128854 DG01128856 DG12107271 DG11118623 DG08118164 DG01128829 DG09118312 DG06117986 DG03106165 DG12118688 DG05117847 DG10118417 DG02128918 DG04106222 DG06106437 DG11118584 DG03117571 DG09118290 DG09106811 DG12107248 DG04106273 DG08106755 DG10106977 DG10106938 DG06117987 DG03106136 DG12118727 DG02128898 DG06106464 DG11107127 DG05106395 DG11107034 DG01128809 DG11118596 DG04129132 DG09106843 DG02117463 DG02106083 DG09118289 DG03117597 DG12107197 DG02117542 DG12118710 DG01128838 DG11118535 DG10118499 DG10118502 DG10118519 DG11118526 DG05117780 DG11118528 DG03117628 DG12118749 
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 188 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.
-
-