Events

Recall of CellTracks Analyzer II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Veridex, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60943
  • Event Risk Class
    Class 2
  • Event Number
    Z-1004-2012
  • Event Initiated Date
    2011-08-17
  • Event Date Posted
    2012-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106849
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
  • Reason
    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.
  • 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.

Device

CellTracks Analyzer II
  • Model / Serial
    K050145 (March 15, 2005); K060110 (March 16, 2006) Product code 9555
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    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.
  • Manufacturer
    Veridex, LLC

Manufacturer

Veridex, LLC
  • Manufacturer Address
    Veridex, LLC, 1001 US Route 202, Raritan NJ 08869-0606
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA