Date Initiated by Firm |
August 17, 2011 |
Date Posted |
February 13, 2012 |
Recall Status1 |
Terminated 3 on June 17, 2015 |
Recall Number |
Z-1004-2012 |
Recall Event ID |
60943 |
510(K)Number |
K050145 K060110 K113181
|
Product Classification |
System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
|
Product |
CellTracks Analyzer II.
A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device. |
Code Information |
K050145 (March 15, 2005); K060110 (March 16, 2006) Product code 9555 |
Recalling Firm/ Manufacturer |
Veridex, LLC 1001 US Route 202 Raritan NJ 08869-0606
|
For Additional Information Contact |
Mr. Joseph Falvo 908-218-1300
|
Manufacturer Reason for Recall |
Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II.
|
FDA Determined Cause 2 |
Software design |
Action |
Veridex, LLC sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated August 17, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides procedure sheets with step by step directions for customers to follow. Additionally, a Confirmation of Receipt form was enclosed for customers to complete and return to the firm. Contact Customer Technical Services at 1-877-837-4339 for questions regarding this notice. |
Quantity in Commerce |
37 Units |
Distribution |
Worldwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = IMMUNICON CORP. 510(K)s with Product Code = NQI and Original Applicant = VERIDEX, LLC
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