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
    130438
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-10
  • 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 system initialization and exactly when the pipettors are washing if either patient sample or reagent area flap (door) are opened the shaker rod may stop moving. this will affect the suspension of magnetic particles resulting in low rlu values for calibrators controls and patient samples giving unexpected positive or negative results or incorrect dose.

Device

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

Manufacturer

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