Events

Recall of Device Recall CellTracks Auto Prep System

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
    55908
  • Event Risk Class
    Class 2
  • Event Number
    Z-2175-2010
  • Event Initiated Date
    2010-05-19
  • Event Date Posted
    2010-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92214
  • 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
    Automated Blood Cell Diluting Apparatus - Product Code GKH
  • Reason
    Complaints of patient sample carryover.
  • Action
    On 19 May 2010, all consignees were notified, US and foreign, via Urgent Product Correction Notification letters. The letter identified the affected product and explained the reason for recall. Customers were asked to follow the required actions provided in the letter, including completing and returning the attached Confirmation of Receipt form. Questions should be directed to Customer Technical Services at 1-877-837-4339.

Device

Device Recall CellTracks Auto Prep System
  • Model / Serial
    Product code 9541
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.
  • Product Description
    CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD || Veridex, LLC || a Johnson & Johnson Company || Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
  • 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