Events

Recall of cobas 8100 BRF and URF with software versions 02-xx. 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-2017-RN-00373-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00373-1
  • 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
    An issue regarding the reformatter modules urf and brf of the cobas 8100 automated workflow series (when used with software version 02-xx) has been identified. this issue is caused by an incorrect mechanical control sequence based on a limitation in software versions 02-xx, resulting in the racks to be shaken and specimen spillage. sample spillage may cause cross contamination of samples and potentially expose operators to infectious material.
  • Action
    Until the installation of the software upgrade, Roche Diagnostics is advising users to ensure that the rack buffering function is disabled in the configuration of the Control Unit. In the event of a major spillage, users are advised to set the affected modules offline. These modules should be checked and cleaned by a Roche Service Representative before being returned to routine operation. This action has been closed-out on 15/03/2018.

Device

cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD)cobas 8100 automated workflow seriesBRF for cobas 8100Material Number: 07439954001URF for cobas 8100Material Number: 07441657001ARTG Number: 173887
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited