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U.S. Department of Health and Human Services

Class 3 Device Recall Cell Search CTC Control Kit

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  Class 3 Device Recall Cell Search CTC Control Kit see related information
Date Initiated by Firm November 09, 2010
Date Posted March 01, 2011
Recall Status1 Terminated 3 on March 28, 2014
Recall Number Z-1472-2011
Recall Event ID 57514
510(K)Number K040898  
Product Classification CTC Control Kit - Product Code NRS
Product Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
Code Information Lot C512; Product code 7900003
Recalling Firm/
Manufacturer		 Veridex, LLC
1001 US Route 202
Raritan NJ 08869-0606
For Additional Information Contact Ms. Jean O' Connor
908-927-3681
Manufacturer Reason
for Recall		 There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.
FDA Determined
Cause 2		 Process control
Action Veridex notified all affected consignees on November 11, 2010 by Federal Express overnight letter and prodivded with the informaiton regarding the label discrepancy. Foreign consignees were also notified on November 11, 2010 of the issue and instructed to notify their affected consignees. Consignees are asked to return the confirmation of receipt form by 11/29/2010.
Quantity in Commerce 122 US, 28 International
Distribution Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal.
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.
510(K) Database 510(K)s with Product Code = NRS and Original Applicant = VERIDEX, LLC
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