Field Safety Notices about Cholesterol FS 5 and others

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 DiaSys Diagnostic Systems 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
  • Date
  • 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
    N-acetylcysteine (nac), acetaminophen and metamizole administered in therapeutic concentrations, will cause interferences in so-called trinder reactions. trinder reactions are based on a color reaction in which hydrogen peroxide (h2o2) is formed and subsequently reacts with amino-antipyrine, a phenol derivative and peroxidase as catalyst. peroxidase reactions are disturbed to different extents by above mentioned medications.


  • Model / Serial
    Cholesterol FS 5 ‘ version 1 1350 .. 10 ‘ version 1 1300 .. Creatinine PAP FS 1 1759 .. Glucose GOD FS 5 ‘ version 1 2550 .. 10 ‘ version 1 2500 .. Glucose/Hemoglobin IS 1 2491 99 10 760 HDL-C Immuno FS 1 3521 .. LDL-C Select FS 1 4121 .. NEFA FS 1 5781 .. Phospholipids FS 1 5741 .. Triglycerides FS 5 ‘ version 1 5760 .. 10 ‘ version 1 5710 .. Uric acid FS TBHBA 1 3021.. Uric acid FS TOOS 1 3001 ..
  • Manufacturer