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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 System see related information
Date Initiated by Firm May 06, 2009
Date Posted August 13, 2009
Recall Status1 Terminated 3 on October 05, 2010
Recall Number Z-1734-2009
Recall Event ID 52079
510(K)Number K040077  
Product Classification Apparatus, automated blood cell diluting - Product Code GKH
Product CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, PA. Immunicon was acquired by Veridex in August of 2008.
Code Information CellTracks AutoPrep: 9541, Waste Bottle CT4256.
Recalling Firm/
Manufacturer		 Veridex, LLC
1001 US Route 202
Raritan NJ 08869-0606
For Additional Information Contact Ken Berlin
908-218-1300
Manufacturer Reason
for Recall		 Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.
FDA Determined
Cause 2		 Device Design
Action Veridex, LLC issued a recall notice to consignees dated March 12, 2009 detailing the affected product. The firm will provide replacement bottles to all customers in the near future. For further questions, contact Veridex Customer Technical Services at 1-877-837-4339.
Quantity in Commerce 196 instruments
Distribution Worldwide Distribution
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 = GKH and Original Applicant = IMMUNICON CORP.
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