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U.S. Department of Health and Human Services

Class 2 Device Recall Janssen Diagnostics, LLC

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  Class 2 Device Recall Janssen Diagnostics, LLC see related information
Date Initiated by Firm January 08, 2014
Date Posted March 13, 2014
Recall Status1 Terminated 3 on July 06, 2017
Recall Number Z-1195-2014
Recall Event ID 67447
510(K)Number K050145  K130794  
Product Classification System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
Product CELLTRACKS ANALYZER II¿ (Product Code 9555)

Product Usage:

The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
Code Information First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555  Serial numbers:   CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024 
Recalling Firm/
Manufacturer		 Veridex, LLC
1001 US Route 202
Raritan NJ 08869-0606
Manufacturer Reason
for Recall		 Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.
FDA Determined
Cause 2		 Device Design
Action Janssen Diagnostics, LLC sent an Important Product Correction Notification letter dated January 8, 2014 to all affected customers via FedEx overnight courier letter and Foreign Affiliate Consignees by email on January 8, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt Response form attached. For questions contact Customer Technical Service at 1-877-837-4339.
Quantity in Commerce 19 units
Distribution Worldwide Distribution - USA Nationwide
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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