Field Safety Notices about Multiplate® Analyzer

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.

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 Country
  • Event Source
  • 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 multiplate® analyzers used with software version 2.04.37 and software version 2.04.39 may generate a wrong reference range and target range graphical printout. the multiplate® analyzer software contains a functionality that allows the reference range and target range to be displayed in the form of horizontal graphical bars. when this functionality is enabled, sample result will be displayed as a black vertical line within the reference/target range graphical bars to indicate its position relative to the set ranges. when sample results are printed, the graphical bars and the sample result line will be printed as well (see figure 1). .


  • Model / Serial
  • Manufacturer