Events

Field Safety Notices about cobas 8000 core unit

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Roche Diagnostics.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-07-20
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    We regret to inform you that we have identified a software limitation, which in rare cases resets your system configuration of the control unit software to default. roche diagnostics received 6 complaints in total regarding this issue. the control unit (cu) settings under utility-system are reset to the default settings, under the following conditions: 1. the date and time in the status line of the user interface is not displayed 2. the information about the “analytical unit” (au) is not displayed in the data review screen (however, it is still displayed in the test review screen) 3. the year/month/date/time of the printout preview on the history screen is not displayed .

Device

cobas 8000 core unit

Manufacturer

Roche Diagnostics