Events

Recall of LIAISON XL SYSTEM - ANALYZER

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
    90240
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-23
  • 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
    Manufacturer became aware of the following: the "calibration expiry date is 9999-12-30 (never expires) could result in incorrect handling of incoming control. frequent pop-up: "the period selected has an sd value of o". several periods may open in parallel for the same control. error codes such as "pump warning 10" and "pump warning 14" appear during initialization of the instrument.

Device

LIAISON XL SYSTEM - ANALYZER
  • Model / Serial
    Model Catalog: I0050 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Manufacturer
    DIASORIN CANADA INC.

Manufacturer

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