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U.S. Department of Health and Human Services

Class 2 Device Recall PerkinElmer Specimen Gate Screening Center software

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  Class 2 Device Recall PerkinElmer Specimen Gate Screening Center software see related information
Date Initiated by Firm June 27, 2014
Date Posted August 07, 2014
Recall Status1 Terminated 3 on April 06, 2015
Recall Number Z-2166-2014
Recall Event ID 68670
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500

Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
Code Information Product Code: 5002-0500; Software Versions, 1.4 and 1.6
Recalling Firm/
Manufacturer		 PerkinElmer Health Sciences, Inc.
940 Winter St
Waltham MA 02451-1457
For Additional Information Contact
800-321-9632
Manufacturer Reason
for Recall		 Potential for demographic information and test result to be mismatch.
FDA Determined
Cause 2		 Software design
Action PerkinElmer sent an Urgent Medical Device Recall letter on July 1, 2014, to all affected customers. The letter informed customers of the recall and provided instructions. Customers were asked to complete the enclosed response form and fax it to 1-330-825-8520. For additional information, customers were instructed to contact their local PerkinElmer representative or email specimen.gate.support@perkinelmer.com. Customers with questions were instructed to call 1-800-321-9632. option 1.
Quantity in Commerce 13 devices
Distribution Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
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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