Events

Recall of LIAISON SYSTEM - H. PYLORI SA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DIASORIN 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
    21492
  • Event Risk Class
    III
  • Event Initiated Date
    2014-12-30
  • 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 liaison h. pylori sa kit reports an incorrect volume for the sample diluent component.Kit content states 40ml and specimen diluent component contains 45mls. the component label and instructions for use are correct at 45ml.

Device

LIAISON SYSTEM - H. PYLORI SA
  • Model / Serial
    Model Catalog: 318920 (Lot serial: 131211B); Model Catalog: 318920 (Lot serial: 131211A)
  • Product Description
    LIAISON SYSTEM - H. PYLORI SA
  • Manufacturer
    DIASORIN INC.

Manufacturer

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