Events

Recall of INDIKO SYSTEM - CLINICAL CHEMISTRY ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DIAGNOSTIX LTD.

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
    30256
  • Event Risk Class
    III
  • Event Initiated Date
    2016-09-23
  • 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
    It was reported on october 2013 that the report-to-file function does not work properly and there is potential for sample id and test results to be mismatched. investigation of the issue by thermo fisher scientific revealed that the report-to-file function was not being used in canada at the time. the software on canadian analyzers was updated at the time of the reported incident.

Device

INDIKO SYSTEM - CLINICAL CHEMISTRY ANALYZER
  • Model / Serial
    Model Catalog: 98631000-9 (Lot serial: 863000090129); Model Catalog: 98630000-0 (Lot serial: 863000090129); Model Catalog: 98640000-9 (Lot serial: 864000090124); Model Catalog: 98641000-0 (Lot serial: 864000090124)
  • Product Description
    Indiko System;INDIKO PLUS
  • Manufacturer
    DIAGNOSTIX LTD

Manufacturer

DIAGNOSTIX LTD