Events

Recall of Device Recall Cell Search CTC Control Kit

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
    57514
  • Event Risk Class
    Class 3
  • Event Number
    Z-1472-2011
  • Event Initiated Date
    2010-11-09
  • Event Date Posted
    2011-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96440
  • 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
    CTC Control Kit - Product Code NRS
  • Reason
    There is a discrepancy between the assigned range of values on the high control label and the range listed on the cell control assigned value label for the cell search circulating tumor cell control kit.
  • Action
    Veridex notified all affected consignees on November 11, 2010 by Federal Express overnight letter and prodivded with the informaiton regarding the label discrepancy. Foreign consignees were also notified on November 11, 2010 of the issue and instructed to notify their affected consignees. Consignees are asked to return the confirmation of receipt form by 11/29/2010.

Device

Device Recall Cell Search CTC Control Kit
  • Model / Serial
    Lot C512; Product code 7900003
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal.
  • Product Description
    Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
  • 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