Events

Recall of cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD)(for use on the cobas 6800/8800 systems)

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-00744-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-06-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00744-1
  • 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 has observed an increased rate of invalid internal control (ic) results for cobas mpx when used with certain lots of the cobas omni mgp reagent. this issue affects only the blood screening assays, cobas mpx. for the non-blood screening assays, these lots of cobas omni mgp reagent continue to meet specifications, and no performance issues have been identified. the cobas 6800/8800 systems will correctly flag a sample result as invalid if the internal control is invalid. there is no risk of generating incorrect patient results as a consequence of this issue. all previously generated valid results and runs remain valid.
  • Action
    Roche is advising customers to restrict the use of affected cobas omni MGP Reagent lots to non-blood screening assays only (CMV; CT/NG; HPV), and discontinue the use of these specific lots with the cobas MPX.

Device

cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD...
  • Model / Serial
    cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD)(for use on the cobas 6800/8800 systems)cobas omni MGP Reagent Material Number: 06997546190Pack Size: 480 testsLot Numbers: W17311, X05638, X05639, X16159ARTG Number: 175163
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited