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U.S. Department of Health and Human Services

Class 2 Device Recall CellTracks Analyzer II

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  Class 2 Device Recall CellTracks Analyzer II see related information
Date Initiated by Firm August 17, 2011
Date Posted February 13, 2012
Recall Status1 Terminated 3 on June 17, 2015
Recall Number Z-1004-2012
Recall Event ID 60943
510(K)Number K050145  K060110  K113181  
Product Classification System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
Product CellTracks Analyzer II.

A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.
Code Information K050145 (March 15, 2005); K060110 (March 16, 2006) Product code 9555
Recalling Firm/
Manufacturer		 Veridex, LLC
1001 US Route 202
Raritan NJ 08869-0606
For Additional Information Contact Mr. Joseph Falvo
908-218-1300
Manufacturer Reason
for Recall		 Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II.
FDA Determined
Cause 2		 Software design
Action Veridex, LLC sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated August 17, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides procedure sheets with step by step directions for customers to follow. Additionally, a Confirmation of Receipt form was enclosed for customers to complete and return to the firm. Contact Customer Technical Services at 1-877-837-4339 for questions regarding this notice.
Quantity in Commerce 37 Units
Distribution Worldwide Distribution.
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 = NQI and Original Applicant = IMMUNICON CORP.
510(K)s with Product Code = NQI and Original Applicant = VERIDEX, LLC
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