Events

Field Safety Notices about INNOVANCE® DTI references with erroneous AnalysisPreset ID

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 Siemens Healthcare Diagnostics Products 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 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
    During internal investigation it has been observed that we provided a defective file to install the innovance dti assay setting on the sysmex 08-5100 system to our field service staff. the provided installation file for the innovance dti assay contains an incorrect analysispreset d. this can cause an invalid calibration curve of the innovance dti assay.

Device

INNOVANCE® DTI references with erroneous AnalysisPreset ID

Manufacturer

Siemens Healthcare Diagnostics Products GmbH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS