Events

Recall of LSI FUS (16P11) DUAL COLOUR BREAKAPART PROBE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTER MEDICO.

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
    40777
  • Event Risk Class
    III
  • Event Initiated Date
    2008-11-11
  • 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
    Through a customer complaint investigation it has been determined that use of the lsi fus breakapart probe may result in an unusual signal pattern for abnormal cells.

Device

LSI FUS (16P11) DUAL COLOUR BREAKAPART PROBE
  • Model / Serial
    Model Catalog: 32-231032 (Lot serial: all lots)
  • Product Description
    LSI FUS DUAL COLOUR BREAKAPART PROBE
  • Manufacturer
    INTER MEDICO

Manufacturer

INTER MEDICO
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Inter Medico
  • Source
    HC