Events

Alerta De Seguridad para Diagnostic Test Analysis Systems

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 Tecan Schweiz Ag || Ortho Clinical Diagnostics || Ortho Clinical Diagnostics.

¿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
    I1701-15
  • Número del evento
    2015DM-0012864
  • Fecha
    2017-01-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=106
  • 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 has detected that if the incubation time parameters are changed when creating a user defined protocol (udp) test, then the incubation time of the ortho test template and other udp tests created from the same template the test can change, leading to errors in the processing, obtaining deviations from the results.

Device

Diagnostic Test Analysis Systems
  • Modelo / Serial
  • Descripción del producto
    ORTHO VISION ANALYZER is a device designed to automate in vitro immunohematological analysis of human blood using ORTHO BIOVUE SYSTEM cassette technology .ORTHO VISION ANALYZER automates the functions of test processing, such as liquid pipetting, reagent handling, incubation, centrifugation, classification and interpretation of the reactions and the requirements for the management of data by means of cassettes and digital image processing.ORTHO VISION ANALYZER can be used as an independent team or connected to the computer system of the client's laboratory (lis).
  • Manufacturer
    Tecan Schweiz Ag || Ortho Clinical Diagnostics || Ortho Clinical Diagnostics

Manufacturer

Tecan Schweiz Ag || Ortho Clinical Diagnostics || Ortho Clinical Diagnostics
  • Source
    NIDFSINVIMA