Events

Alerta De Seguridad para Analyzer for Enzymatic Immunoassays AIA

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 Tosoh AIA || Tosoh Bioscience, Inc..

¿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
    I1802-106
  • Número del evento
    2012DM-0009432
  • Fecha
    2018-02-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=55
  • 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 the photo switch (pi) in the previous analyzers may malfunction due to aging and deterioration of the current of the pi collector, this could lead to delays in the processing of the samples.

Device

Analyzer for Enzymatic Immunoassays AIA
  • Modelo / Serial
    AIA-900, AIA-900 with 9 bin sorter, AIA-900 with sorter
  • Descripción del producto
    The AOS team of TOSIOH are automated analyzers (AIA900) and (AIA2000) of medium and high volume for high performance immunoassay for in-vitro diagnosis. It is designed for the assembly, processing and reading of Elisa tests. Sequential processes comprising an Elisa assay (sample pipetting, incubation, washing, reagent dispensing, stirring, optical density measurement and data deduction) are automatically performed according to specific test protocols.
  • Manufacturer
    Tosoh AIA || Tosoh Bioscience, Inc.

Manufacturer

Tosoh AIA || Tosoh Bioscience, Inc.
  • Empresa matriz del fabricante (2017)
    Tosoh Corp.
  • Source
    NIDFSINVIMA