Events

Recall of Device Recall Janssen Diagnostics, LLC

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
    67447
  • Event Risk Class
    Class 2
  • Event Number
    Z-1195-2014
  • Event Initiated Date
    2014-01-08
  • Event Date Posted
    2014-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125466
  • 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
    Janssen diagnostics, llc received complaints of camera failures on the celltracks analyzer ii¿.
  • Action
    Janssen Diagnostics, LLC sent an Important Product Correction Notification letter dated January 8, 2014 to all affected customers via FedEx overnight courier letter and Foreign Affiliate Consignees by email on January 8, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt Response form attached. For questions contact Customer Technical Service at 1-877-837-4339.

Device

Device Recall Janssen Diagnostics, LLC
  • Model / Serial
    First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555  Serial numbers:   CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Product Description
    CELLTRACKS ANALYZER II¿ (Product Code 9555) || Product Usage: || The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
  • 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