Events

Alerta De Seguridad para urine 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 N/A.

¿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
  • Número del evento
    2014DM-0011237 ; 2014DM-0011773
  • Fecha
    2018-02-07
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=56
  • 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

Device

urine analyzer
  • Modelo / Serial
    u601 and u701, specific serials.
  • Descripción del producto
    The urine analyzer cobas u 601 (called the urine analyzer in a generic way) is a fully automated urinalysis system designed for the qualitative quantitative in vitro quantitative determination of urinary analytes, such as PH, leukocytes, nitrites, proteins, glucose, ketones, urobilinogen, bilirubin yerithrocytes, as well as specific density, color and turbidity. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by qualified operators in clinical laboratories. The analyzer can process up to 240 samples per hour. It is automated.The team cobas u 701 MICROSCOPY ANALYZER (denominadomicroscopio analyzer) is an orinatotalmente automated microscopy system designed for the quantitative invitro determination of erythrocytes and leukocytes, for the semiquantitative determination of squamous and non-squamous epithelial cells, bacteria and cylindershyaline and for the qualitative determination of pathological cylinders, crystals, yeast, mucus and sperm in the urine. The instrument consists of a microscopy system which increases the urinary sediment of the patients sample and presents them on an LCD screen for reading and review by the laboratory professional. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by operators qualified in clinical laboratories.
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA