Events

Recall of Autostainer Link 48, AS480 Software version: Dako Link software 4.0.3

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Dako 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-01065-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01065-1
  • 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
    Dako has found a software defect in the calibration routine of dakolink 4.0. the defect may cause the autostainer control software to use old calibration settings.
  • Action
    Dako implemented a software update to correct the issue. This action has been closed -out on 28/01/2016 This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Autostainer Link 48, AS480 Software version: Dako Link software 4.0.3
  • Model / Serial
    Autostainer Link 48, AS480Software version: Dako Link software 4.0.3
  • Manufacturer
    Dako Australia Pty Ltd

Manufacturer

Dako Australia Pty Ltd