Events

Alerte De Sécurité sur Clinitek uroanalysis analyzer

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1508-355
  • Numéro de l'événement
    2014DM-0011303
  • Date
    2015-08-03
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=174
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer states that it has identified a potential error in the reports obtained with the referenced analyzer, if the clarity report adjustment is disabled, leading to potential failures in the analysis of samples and subsequent diagnosis.

Device

Clinitek uroanalysis analyzer
  • Modèle / numéro de série
    NOVUS WITH RACK, serial S001046, S001259, S001294, S001295, S001308, S001331, S001333, S001524, S001555, || S001311, S001312, S001313, S001328, S001520, S001550, || S001553 and S001569
  • Description du dispositif
    The CLINITEK NOVUS ™ automatic urine chemical analyzer is a fully automated urine analyzer. It is designed for professional use in vitro diagnosis. The CLINITEK NOVUS analyzer is designed to read only SIEMENSHEALTHCARE DIAGNOSTICS CLINITEK NOVUS cassettes. Elanalizer is designed to measure the following components of urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leukocytes, nitrite, ph, proteins, urobilinogen, density (specific gravity), albumin-creatinine ratio and protein-creatinine ratio. These measures are used to help make the diagnosis in the following areas: carbohydrate metabolism (such as diabetes mellitus), kidney function, liver function, metabolic disorders, urinary tract infections the analyzer reports the color and appearance of the sample. The automatic urine analyzerCLINITEK NOVUS is designed for centralized laboratories.
  • Manufacturer
    Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited

Manufacturer

Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA