Events

Alerta De Seguridad para Accelerator A3600

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 Inpeco S.P.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
  • ID del evento
    A1606-230
  • Número del evento
    2013DM-0010218
  • Fecha
    2016-06-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=138
  • 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 informs that he has received a statement from the distributor of the centrifugationreferenced module, in which he recommends immediately reducing the speed of the centrifugation and not exceeding the maximum speed of 3,500rpm, since changes in the material may affect the mechanical strength of the rotor vessels. therefore it could leave its housing in the centrifuge, which may lead to potentially serious adverse events occurring to the user.

Device

Accelerator A3600
  • Modelo / Serial
    Concerning the centrifugation module reference 06P37.
  • Descripción del producto
    Designed to automate pre-analytical and post-analytical processing, in order to automate the processing of samples in the laboratory
  • Manufacturer
    Inpeco S.P.A.

Manufacturer

Inpeco S.P.A.