Events

Recall of COBAS INTEGRA 800 Software Version 9864.C2. 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-2013-RN-00926-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-09-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00926-1
  • 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
    A software bug has been detected in the cobas integra 800 software version 9864.C2 which affects the execution of routine maintenance of the ise module. the issue is caused by the ise counters in the software being reset to zero whenever the ise rack is removed from the analyser. lf ise service actions and manual maintenance items are not executed at their recommended intervals, there is a potential risk of increased occurrence of calibration flags (slope, sol i dev etc), as well as incorrect and unflagged ise results.
  • Action
    Roche is currently working on a software fix expected to be implemented by the end of the year. Until the software is available, Roche recommends that operators manually track all ISE counters and to manually request the corresponding Service Action in the Service Software.

Device

COBAS INTEGRA 800 Software Version 9864.C2. An in vitro diagnostic medical device (IVD).

Manufacturer

Roche Diagnostics Australia Pty Limited