Events

Recall of Indiko and Indiko Plus Chemistry Analysers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Thermo Fisher Scientific Australia Pty 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
    RC-2014-RN-00212-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00212-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Internal investigations have revealed that cuvettes intermittently may be used twice, and as a consequence there is the potential for erroneous results to be generated without the operator being aware that this has occurred.
  • Action
    Thermofisher is advising all end users to immediately stop using any analyser with software versions prior to 5.1.1. Thermo Fisher will provide their customers with a mandatory update to software version 5.1.1. Technical Support will be contacting customers as a matter of urgency to schedule the update.

Device

Indiko and Indiko Plus Chemistry Analysers

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd