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
    I1605-199
  • Número del evento
    2012DM-0009432
  • Fecha
    2016-05-10
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=142
  • 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 identified that the accumulation of data in the bases of the referenced device could slow down and present the code of error 2032 "there is no answer to the question" causing problems in the coincidence of results, which could lead to the occurrence of potentially adverse events about patients and loss of results on the front.

Device

Analyzer for Enzymatic Immunoassays AIA
  • Modelo / Serial
    AIA-1800ST, AFP-1800LA, AIA-2000ST and AFP-200LA
  • Descripción del producto
    The TOSOH AIA equipment is an automated analyzer (AIA900) and (AIA2000) of medium and high volume for high performance parainmunoassay for in-vitro diagnostics. It is designed for the assembly, processing and reading of elisa assays. Sequential processes that comprise 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