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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 FirmJune 03, 2015
Date PostedJuly 20, 2015
Recall Status1 Terminated 3 on August 04, 2017
Recall NumberZ-2128-2015
Recall Event ID 71380
Product Classification Counter (beta, gamma) for clinical use - Product Code JJJ
ProductPerkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Code Information Serial Numbers: Model: 2470-0150 (1 unit): SGWZ36130042 Model: 3470-0150 (1 unit): SGWZ19140141  
Recalling Firm/
Manufacturer		 Perkinelmer
940 Winter Street
Waltham MA 02451
For Additional Information ContactAubrey Doyle
774-278-6455
Manufacturer Reason
for Recall		Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPerkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com
Quantity in Commerce2 units
DistributionWorldwide Distribution-US (nationwide) and the countries of ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CHINA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ETHIOPIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LUXEMBOURG MEXICO MYANMAR NETHERLANDS NORWAY PHILIPPINES POLAND REUNION SAUDIA ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UK.
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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