Events

Recall of Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)

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-2012-RN-01198-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01198-1
  • 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
    Based on an investigation it has been concluded that the expected lifetime of the coverstainer racks does not meet the set requirements. the consequence can be that slides are falling out of the rack during the staining process. slides falling out of the rack during the staining process would require a new slide preparation and staining process to be initiated. in the rare event, the patient may need to be called in for a new sample to be taken.This recall action was not notified to the tga before it was initiated by dako australia.
  • Action
    Dako Australia Pty Ltd has advised their customer to discontinue use and return the Coverstainer Slide Racks for replacement.

Device

Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)Model number: CS10330ARTG: 181957
  • Manufacturer
    Dako Australia Pty Ltd

Manufacturer

Dako Australia Pty Ltd