Events

Recall of LIAISON SYSTEM - INSTRUMENT CLASS III

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
    31959
  • Event Risk Class
    III
  • Event Initiated Date
    2011-02-17
  • 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
    The contact manufacturer informed diasorin inc. of the potential for the premature failure of certain cooling modules. the affected cooling modules were assembled incorrectly and as a result heat generated by the peltier (thermo-electric cooler) units of the cooling module may not be properly dissipated. the heat build up may shorten the expected lifespan of the cooling module. failure of the cooling module could cause the temperature in the liaison analyzer reagent area to exceed allowable limits.

Device

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

Manufacturer

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