Events

Recall of Cobas 8000 'v2' instrument drivers for Cobas IT 3000 (Used with Cobas IT 3000 versions 2.03.08 to 2.04.00); 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-2012-RN-00783-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00783-3
  • 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
    There is a potential for incorrect handling of extra-long result messages that are sent form the cobas® 8000 data manager and received into it 3000 using a “v2” instrument driver. this is applicable for messages that are greater than 33 results in length per episode and if the configuration of the predefined buffer size is not optimal. the “v2” instrument drivers for cobas® 8000 use a buffer to ensure that extra-long result messages are processed correctly. if this buffer is not configured for the specific driver that is installed, then there can be a mismatch in the amount of data that is truncated. the effect of this being that results and flags after result #33 in the string may be delayed and in some cases may not be reported to cobas® it 3000.
  • Action
    Roche are providing work around instructions until a software upgrade can be implemented to permanently fix the issue.

Device

Cobas 8000 'v2' instrument drivers for Cobas IT 3000 (Used with Cobas IT 3000 versions 2.03.08 to...
  • Model / Serial
    Cobas 8000 'v2' instrument drivers for Cobas IT 3000 (Used with Cobas IT 3000 versions 2.03.08 to 2.04.00); An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited