Events

Recall of cobas 6800 system - cobas MPX, 96 tests and cobas MPX, 480 tests. An in-vitro diagnostic medical device (IVD). cobas MPX, 96 tests

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-00833-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00833-1
  • 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 diagnostics australia is informing users that in extremely rare cases, sample under-aspiration may occur when using the cobas 6800 system with sample input volumes of less than 450 µl. this issue will only affect the cobas mpx test when used with cadaveric donors, since the minimum sample volume required for cadaveric donors is 300 µl (for living donors, the minimum sample volume required is 1,000 µl).If bubbles or foam are present in the sample tube, this may lead to false sample liquid level detection and under-aspiration of the sample. this could potentially cause false negative / under-quantitated results that are not flagged.
  • Action
    Roche is advising users to ensure good sample preparation technique to avoid the formation of foam, clots, or bubbles in all samples, as described within the instrument safety manual. A look-back at previous cadaveric results is also recommended. Roche will be implementing a software correction as a permanent fix..

Device

cobas 6800 system - cobas MPX, 96 tests and cobas MPX, 480 tests. An in-vitro diagnostic medical ...
  • Model / Serial
    cobas 6800 system - cobas MPX, 96 tests and cobas MPX, 480 tests. An in-vitro diagnostic medical device (IVD). cobas MPX, 96 testsMaterial Number: 06997708190All Lot Numbers affectedcobas MPX, 480 testsMaterial Number: 06997716190All Lot Numbers affectedARTG Number: 275469
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited