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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) IVDsee related information
Date Initiated by FirmAugust 12, 2009
Date PostedFebruary 23, 2010
Recall Status1 Terminated 3 on July 18, 2012
Recall NumberZ-0819-2010
Recall Event ID 53025
510(K)NumberK073338 
Product Classification Immunomagnetic circulating cancer cell selection and enumeration system - Product Code NQI
ProductCellSearch 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.
FEI Number 3004619490
Recalling Firm/
Manufacturer		 Veridex, LLC
1001 US Route 202
Raritan NJ 08869-0606
For Additional Information ContactBarbara 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
ActionUrgent 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 Commerce1641 in US, 380 internationally.
DistributionProduct 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 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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