Field Safety Notices about Cholesterol, CHOD‐PAP, Cholesterol HDL Direct, immunoinhibition, Cholesterol LDL Direct, enzymatic selective protection Creatinine, enzymatic, PAP; 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 DIALAB – Produktion und Vertrieb von chemisch‐technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.

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 colour reaction in which hydrogen peroxide (h2o2) is formed and subsequently reacts with amino‐antipyrine, a phenol derivate and peroxidase as catalyst. peroxidase reactions are disturbed to different extents by above mentioned medications. .