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
    29468
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-25
  • 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
    A new cuvette does not always replace the old used cuvette from the incubator. as a result a new sample might be dispensed to an already used cuvette causing an erroneous result.

Device

INDIKO SYSTEM - CLINICAL CHEMISTRY ANALYZER
  • Model / Serial
    Model Catalog: 98630000-0 INDIKO (Lot serial: n/a); Model Catalog: 9864 0000-0 (Lot serial: n/a)
  • Product Description
    INDIKO
  • Manufacturer
    DIAGNOSTIX LTD

Manufacturer

DIAGNOSTIX LTD