Events

Alerta De Seguridad para Ortho Vision 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 Ortho Clinical Diagnostics || Tecan Schweiz Ag.

¿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
    I1603-105
  • Número del evento
    2015DM-0012864
  • Fecha
    2016-03-15
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=151
  • 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 an unlikely scenario in which a user improperly removes or exchanges the samples in a sample rack on board or removes a dilution tray on board after making the request to load / download reagents (reagents load / unload), if an inappropriate change is made in the site of the decarga station that was not selected through the user graphic interface (gui), the system will not detect the change, which could lead to the affectation of the results obtained in the processing of the samples.

Device

Ortho Vision analyzer
  • Modelo / Serial
    6904578 and 6904579, serial 60002080, 60002096 and 60002277.
  • Descripción del producto
    ORTHO VISION ANALYZER is a device designed to automate in vitro immunohematological analysis of human blood using ORTHOBIOVUE SYSTEM cassette technology. ORTHO VISION ANALYZER automates test processing functions, such as liquid pipetting, reagent handling, incubation, centrifugation, classification and interpretation of reactions and requirements for data management using cassettes and digital image processing. ORTHO VISION ANALYZER can be used as an independent device or connected to the customer's computer system (LIS).
  • Manufacturer
    Ortho Clinical Diagnostics || Tecan Schweiz Ag

Manufacturer

Ortho Clinical Diagnostics || Tecan Schweiz Ag