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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 Device Recall CELLTRACKS AUTOPREP Systemsee related information
Date Initiated by FirmDecember 28, 2012
Date PostedAugust 10, 2013
Recall Status1 Terminated 3 on August 11, 2015
Recall NumberZ-1949-2013
Recall Event ID 64304
510(K)NumberK110406 K122821 
Product Classification System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
ProductCELLTRACKS 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).  
FEI Number 3004619490
Recalling Firm/
Manufacturer		 Veridex, LLC
1001 US Route 202
Raritan NJ 08869-0606
For Additional Information ContactJoseph 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		Software design
ActionVeridex 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 CommerceUS: 82 Units; Ex-US 78 Units.
DistributionWorldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NQI
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