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U.S. Department of Health and Human Services

Class 2 Device Recall CELLTRACKS AUTOPREP System

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 Class 2 Recall
CELLTRACKS AUTOPREP System
see related information
Date Posted August 10, 2013
Recall Status1 Open
Recall Number Z-1949-2013
Recall Event ID 64304
Premarket Notification
510(K) Numbers
K110406  K122821 
Product Classification System, Immunomagnetic, Circulating Cancer Cell, Enumeration - Product Code NQI
Product CELLTRACKS AUTOPREP System (Software Version 2.4.1 & 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 AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation.
Code Information CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below). Product Code: CT4297B (9541).
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: 82 Units; Ex-US 78 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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