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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 Recall
CELLTRACKS ANALYZER II
see related information
Date Posted August 10, 2013
Recall Status1 Open
Recall Number Z-1950-2013
Recall Event ID 64304
Premarket Notification
510(K) Numbers
K110406  K122821 
Product Classification System, Immunomagnetic, Circulating Cancer Cell, Enumeration - Product Code NQI
Product CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data.
Code Information CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below). Product Code: CT1476B (9555).
Recalling Firm/
Manufacturer
Veridex, LLC
1001 US Route 202
Raritan, New Jersey 08869-0606
For Additional Information Contact Joseph Falvo
585-218-1300
Manufacturer Reason
for Recall
Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II.
FDA Determined
Cause 2
DESIGN: Software Design
Action Veridex sent an Important Product Correction Notification letter dated December 28, 2012, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311.
Quantity in Commerce US: 70 Units; Ex-US 76 Units
Distribution Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NQI and Original Applicant = VERIDEX, LLC
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