Recall of iVIEW DAB Detecion Kit. || Catalog Number 760-091

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
    26321
  • Event Risk Class
    Class 3
  • Event Number
    Z-0928-03
  • Event Initiated Date
    2003-05-07
  • Event Date Posted
    2003-06-17
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2004-05-03
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Reagent, Immunoassay, Igg - Product Code KTO
  • Reason
    Kit does not stain tissues properly.
  • Action
    Recall notification was made by telephone on May 6 and 7, 2003. A faxed letter and response form followed.

Device

Manufacturer

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