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
    64304
  • Event Risk Class
    Class 2
  • Event Number
    Z-1949-2013
  • Event Initiated Date
    2012-12-28
  • Event Date Posted
    2013-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115786
  • 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
    Veridex, llc has received a report that a patient's demographics were incorrectly associated with another patient's identification (pid) number. the purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your celltracks autoprep system and celltracks analyzer ii.
  • Action
    Veridex sent an Important Product Correction Notification letter dated December 28, 2012, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311.

Device

Device Recall CELLTRACKS AUTOPREP System
  • Model / Serial
    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below). Product Code: CT4297B (9541).
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of Australia, Canada, China, India, Japan, Singapore, England, France, Germany, Italy and Spain.
  • Product Description
    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. || Product Usage: || The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation.
  • 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