Events

Recall of CellSearch Circulating Tumor Cell Kit (Epithelial) IVD

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
    53025
  • Event Risk Class
    Class 2
  • Event Number
    Z-0819-2010
  • Event Initiated Date
    2009-08-12
  • Event Date Posted
    2010-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84478
  • 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
    Immunomagnetic circulating cancer cell selection and enumeration system - Product Code NQI
  • Reason
    Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of cellsearch circulating tumor cell kit. delayed detection of disease relapse or progression may occur due to false low ctc results.
  • Action
    Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose option 1).

Device

CellSearch Circulating Tumor Cell Kit (Epithelial) IVD
  • Model / Serial
    Lot number 0019, Exp 1/8/2010; 0019B, Exp 1/8/2010; 0039, Exp 3/16/2010; 0059, Exp 3/6/2010, 0079, Exp 2/20/2010; 0099, Exp 6/24/2010.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel.
  • Product Description
    CellSearch Circulating Tumor Cell Kit (Epithelial) IVD || REF 7900001 || Veridex LLC, a Johnson & Johnson Company.
  • 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