Events

Recall of ENVISION FLEX HIGH PH (DAKO OMNIS)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGILENT TECHNOLOGIES CANADA 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
    56245
  • Event Risk Class
    II
  • Event Initiated Date
    2015-09-01
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    An increasing number of complaints regarding the dako envision detection system have been noted. several customers using four antibodies against the biomarkers epstein-barr virus mum-1 smooth muscle actin and wilms tumor 1 protein have reported non-specific background staining that has in some instances interfered with interpretation of the staining results. to date only the four identified antibodies have exhibited the non-specific background staining.

Device

ENVISION FLEX HIGH PH (DAKO OMNIS)
  • Model / Serial
    Model Catalog: GV800 (Lot serial: 20019102); Model Catalog: GV800 (Lot serial: 20019103); Model Catalog: K8002 (Lot serial: 20019102); Model Catalog: K8002 (Lot serial: 20019103)
  • Product Description
    Envision Flex/HRP (Dako Omnis)
  • Manufacturer
    AGILENT TECHNOLOGIES CANADA INC.

Manufacturer

AGILENT TECHNOLOGIES CANADA INC.