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U.S. Department of Health and Human Services

Class 2 Device Recall Cell Search Circulating Tumor Kit

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 Class 2 Device Recall Cell Search Circulating Tumor Kitsee related information
Date Initiated by FirmMay 15, 2015
Date PostedAugust 18, 2015
Recall Status1 Terminated 3 on March 30, 2016
Recall NumberZ-2406-2015
Recall Event ID 71673
510(K)NumberK103502 
Product Classification System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
ProductCell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Code Information Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12
FEI Number 3004619490
Recalling Firm/
Manufacturer		 Veridex, LLC
1001 US Route 202
Raritan NJ 08869-0606
For Additional Information Contact
908-218-1300
Manufacturer Reason
for Recall		Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.
FDA Determined
Cause 2		Under Investigation by firm
ActionJanssen Diagnostics, LLC sent a urgent product correction notification/customer confirmation of receipt on 5/15/2015 via Fed Ex.
Quantity in Commerce1560 kits
DistributionNationwide Distribution.
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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