Events

Field Safety Notices about incorrect operation of the software in the database on cobas e 411 analyzers

According to Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, this field safety notices involved a device in Poland that was produced by Roche Diagnostics GmbH.

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
  • Event ID
    295
  • Date
    2017-07-20
  • Event Country
    Poland
  • Event Source
    ORMPMDBP
  • Event Source URL
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-roche-diagnostics-gmbh-dotycz%C4%85ca-nieprawid%C5%82owego-dzia%C5%82ania
  • Notes / Alerts
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Extra notes in the data
  • Action
    Safety note from Roche Diagnostics GmbH regarding software malfunction in the database on cobas e 411 analyzers by Hitachi High Technologies Corporation

Device

incorrect operation of the software in the database on cobas e 411 analyzers

Manufacturer

Roche Diagnostics GmbH