Events

Recall of Device Recall CellTracks AutoPrep 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
    52079
  • Event Risk Class
    Class 2
  • Event Number
    Z-1734-2009
  • Event Initiated Date
    2009-05-06
  • Event Date Posted
    2009-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82042
  • 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
    Apparatus, automated blood cell diluting - Product Code GKH
  • Reason
    Bottle degradation: investigation has determined that degradation may occur in the plastic waste bottle of the celltracks autoprep system.
  • Action
    Veridex, LLC issued a recall notice to consignees dated March 12, 2009 detailing the affected product. The firm will provide replacement bottles to all customers in the near future. For further questions, contact Veridex Customer Technical Services at 1-877-837-4339.

Device

Device Recall CellTracks AutoPrep System
  • Model / Serial
    CellTracks AutoPrep: 9541, Waste Bottle CT4256.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, PA. Immunicon was acquired by Veridex in August of 2008.
  • 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