Events

Recall of cobas MPX test. 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-2018-RN-00356-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00356-1
  • 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
    Globally, roche has received a number of customer reports of selected lots of the cobas mpx test generating unexpected initial false reactive results, which do not match the serology profile of the sample. roche diagnostics australia has received no reports of false reactive results with the affected lot numbers from australian customers.
  • Action
    Roche is requesting users to discontinue use of and discard any remaining inventory of the affected lots, on receipt of replacement unaffected stock. A Roche Diagnostics Australia representative will be in touch with any affected customers to arrange replacement stock.

Device

cobas MPX test. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    cobas MPX test. An in vitro diagnostic medical device (IVD). Material Number: 06997708190 (96 tests)Lot Numbers: 242567 and 267989ARTG Number: 275469Roche Diagnostics Australia - cobas MPX. - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited