Events

Recall of Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. 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 Roche Diagnostics Australia Pty Limited.

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-2016-RN-01279-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01279-1
  • 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
    Roche is updating the cleaning procedure for rack trays that are used with various cobas, modular analytics and urisys instruments as a result of reports of injury caused by sharp edges on the rack trays during cleaning. cuts may occur when fingers come in contact with rack tray edges, especially if a quick wiping movement is made along the edges of the rack tray. the updated cleaning procedure contains instructions for safe handling of the parts to avoid the risk of injury.
  • Action
    Roche is providing users with updated cleaning instructions for the rack trays. This information will be incorporated into future versions of the respective instrument Operator Manuals. This action has been closed-out on 17/05/2017.

Device

Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnos...
  • Model / Serial
    Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnostic medical device (IVD). Various Rack Trays and instruments affectedMultiple Material Numbers affectedARTG Numbers: 173887 & 212706
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited