Events

Recall of cobas Product System Manager (PSM) (Analyser software), all versions. 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-01256-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01256-1
  • 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
    Psm can be configured to block the validation of patient results in the event of a qc failure. this mechanism may not function as expected if the analyser system time is ahead of the psm system time by more than 2 minutes.
  • Action
    As an interim measure, the sponsor is providing work around instructions to reduce the probability of occurrence. A software update will be installed to permanently correct the issue as soon as possible.

Device

cobas Product System Manager (PSM) (Analyser software), all versions. An in vitro diagnostic medi...

Manufacturer

Roche Diagnostics Australia Pty Limited