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U.S. Department of Health and Human Services

Class 2 Device Recall CellSearch Circulating Tumor Cell Kit (Epithelial) IVD

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  Class 2 Device Recall CellSearch Circulating Tumor Cell Kit (Epithelial) IVD see related information
Date Initiated by Firm August 12, 2009
Date Posted February 23, 2010
Recall Status1 Terminated 3 on July 18, 2012
Recall Number Z-0819-2010
Recall Event ID 53025
510(K)Number K073338  
Product Classification Immunomagnetic circulating cancer cell selection and enumeration system - Product Code NQI
Product CellSearch Circulating Tumor Cell Kit (Epithelial) IVD
REF 7900001
Veridex LLC, a Johnson & Johnson Company.
Code Information Lot number 0019, Exp 1/8/2010; 0019B, Exp 1/8/2010; 0039, Exp 3/16/2010; 0059, Exp 3/6/2010, 0079, Exp 2/20/2010; 0099, Exp 6/24/2010.
Recalling Firm/
Manufacturer		 Veridex, LLC
1001 US Route 202
Raritan NJ 08869-0606
For Additional Information Contact Barbara Schwartz, Ph.D.
908-218-1300
Manufacturer Reason
for Recall		 Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression may occur due to false low CTC results.
FDA Determined
Cause 2		 Other
Action Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose option 1).
Quantity in Commerce 1641 in US, 380 internationally.
Distribution Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel.
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 = NQI and Original Applicant = VERIDEX, LLC
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