Events

Field Safety Notices about Glucose, 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 Thermo Fisher Scientific Inc..

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
    2015-09-22
  • 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
    N-acetylcysteine (nac), acetaminophen via its metabolite n-acetyl-p-benzoquinone imine (napqi), and metamizole may cause interferences in so-called trinder reactions. trinder reactions are based on a colorimetric reaction between hydrogen peroxide (h2o2), aminoantipyrine and a phenol derivate catalyzed in the presence of a peroxidase. peroxidase reactions might be interfered by above mentioned medications, which may lead to falsely low recovery. it has been recently noticed that the above mentioned possible interference applies widely to products with trinder methodology, regardless of the manufacturer. .

Device

Glucose, and others
  • Model / Serial
    Glucose (GOD-POD) 981379, 981780 Uric Acid (AOX) 981391, 981788 All Lots Triglycerides 981301, 981786 Cholesterol 981812, 981813 Creatinine (Enzymatic) 981845, 981896 HDL- Cholesterol Plus 981824,981823 LDL-Cholesterol 981656
  • Manufacturer
    Thermo Fisher Scientific Inc.

Manufacturer

Thermo Fisher Scientific Inc.