Events

Avis De Sécurité sur Glucose, and others

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Thermo Fisher Scientific Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2015-09-22
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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.