Events

Alerta De Seguridad para LUMINEX Fluoroanalyzer

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 Luminex Corporation || Immucor Transplant Diagnostics, 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
    R1704-142
  • Número del evento
    2010DM-0006525
  • Fecha
    2017-04-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=93
  • 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 the client has reported problems since the month of the connectivity between the xponent 4.2 software and the medical device, which have been presented in a randomized manner, these problems are manifested with the error message "error getting device property" and subsequent blocking of the software, being necessary to restart the pc and analyzer to solve the inconvenience, leading to potentially delays in the processing of the samples and subsequent obtaining results.

Device

LUMINEX Fluoroanalyzer
  • Modelo / Serial
  • Descripción del producto
    The LUMINEX 200 system is designed for a wide range of laboratory test applications that measure biomolecular reactions on the surface of XMAP microspheres. This system is designed for the use of in-vitro diagnostics. The LUMINEX200 system is classified according to FDA 21 CFR 1040.10 and 1040.11 as a class II laser product consisting of a class I laser product (LUMINEX 200 analyzer) and a class II laser product (bar code reader).
  • Manufacturer
    Luminex Corporation || Immucor Transplant Diagnostics, Inc

Manufacturer

Luminex Corporation || Immucor Transplant Diagnostics, Inc
  • Source
    NIDFSINVIMA