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U.S. Department of Health and Human Services

Class 2 Device Recall CellTracks Auto Prep System

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 Class 2 Device Recall CellTracks Auto Prep Systemsee related information
Date Initiated by FirmMay 19, 2010
Date PostedAugust 05, 2010
Recall Status1 Terminated 3 on May 08, 2014
Recall NumberZ-2175-2010
Recall Event ID 55908
510(K)NumberK040077 
Product Classification Automated Blood Cell Diluting Apparatus - Product Code GKH
ProductCellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Code Information Product code 9541
FEI Number 3004619490
Recalling Firm/
Manufacturer		 Veridex, LLC
1001 US Route 202
Raritan NJ 08869-0606
For Additional Information ContactMr. Joseph Falvo
585-453-3452
Manufacturer Reason
for Recall		Complaints of patient sample carryover.
FDA Determined
Cause 2		Process control
ActionOn 19 May 2010, all consignees were notified, US and foreign, via Urgent Product Correction Notification letters. The letter identified the affected product and explained the reason for recall. Customers were asked to follow the required actions provided in the letter, including completing and returning the attached Confirmation of Receipt form. Questions should be directed to Customer Technical Services at 1-877-837-4339.
Quantity in Commerce101 Domestically, 87 Internationally
DistributionWorldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.
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 = GKH
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