Events

Recall of HER2 FISH SYSTEM - 30 TEST

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA BIOSYSTEMS RICHMOND 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
    64362
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-25
  • 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
    Leica biosystems recently became aware that ta9217 lot 26806 contains mislabelled bond open containers. the containers display a research use only (ruo) label and the inclusion of these containers as part of the leica her2 fish system will prevent the user to be able to run the test. the bond instrument data management system (dms) software will not allow the ruo-labelled bond open container to be used as part of the sytsem.

Device

HER2 FISH SYSTEM - 30 TEST

Manufacturer

LEICA BIOSYSTEMS RICHMOND INC.