Events

Alerta De Seguridad para Clinitek uroanalysis analyzer

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1508-355
  • Número del evento
    2014DM-0011303
  • Fecha
    2015-08-03
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=174
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    NOVUS WITH RACK, serial S001046, S001259, S001294, S001295, S001308, S001331, S001333, S001524, S001555, || S001311, S001312, S001313, S001328, S001520, S001550, || S001553 and S001569
  • Descripción del producto
    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
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA