Events

Recall of CONFIRM c-KIT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ventana Medical Systems Inc.

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
    26070
  • Event Risk Class
    Class 3
  • Event Number
    Z-0115-04
  • Event Initiated Date
    2003-04-04
  • Event Date Posted
    2003-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26994
  • 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
    Immunohistochemistry Antibody Assay, C-Kit - Product Code NKF
  • Reason
    Increased level of non-specific or background staining.
  • Action
    Customers were sent notice via letter on 4/4/2003. Confirmation of delivery has been obtained for all customers. Product recovery is underway.

Device

CONFIRM c-KIT
  • Model / Serial
    Lot Numbers; 23095A, 23340A, and 30116A.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide and to Japan, France and Puerto Rico.
  • Product Description
    CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • Manufacturer Address
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85737
  • Source
    USFDA