Events

Notificaciones De Seguridad De Campo acerca de Glucose, and others

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Thermo Fisher Scientific Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2015-09-22
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / 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.