Events

Recall of LIAISON SYSTEM - INSTRUMENT CLASS 2

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DIASORIN 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
    22828
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-27
  • 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
    During the manufacture of liasion analyzers two dilutor syringes malfunctioned. the glass body of the syringe became detached from the metal collar. the defect does not affect all dilutor syringes and all reported failures in the field have occurred within a week after installation during routine use.

Device

LIAISON SYSTEM - INSTRUMENT CLASS 2
  • Model / Serial
    Model Catalog: 15970 (Lot serial: ALL LOTS)
  • Product Description
    LIAISON ANALYZER
  • Manufacturer
    DIASORIN CANADA INC.

Manufacturer

DIASORIN CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    HC