Date Initiated by Firm |
May 15, 2015 |
Date Posted |
August 18, 2015 |
Recall Status1 |
Terminated 3 on March 30, 2016 |
Recall Number |
Z-2406-2015 |
Recall Event ID |
71673 |
510(K)Number |
K103502
|
Product Classification |
System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
|
Product |
Cell 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 |
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 |
Action |
Janssen Diagnostics, LLC sent a urgent product correction notification/customer confirmation of receipt on 5/15/2015 via Fed Ex. |
Quantity in Commerce |
1560 kits |
Distribution |
Nationwide 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 = NQI and Original Applicant = VERIDEX, LLC
|