Events

Alerta De Seguridad para Architect Stat High Sensitive Troponin-I

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 Importer: ABBOTT LABORATORIES DE COLOMBIA S.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
    ARD-010516
  • Número del evento
    INVIMA 2013RD-0002487
  • Fecha
    2016-05-03
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=143
  • 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
    Abbott has identified a possible increase in decalibration failures before the expiration date. the reason for this situation is being investigated to find appropriate corrective measures in the long term. it does not affect the results of patients generated. there may be a delay in the generation of results due to calibration errors and calibration failures.

Device

Architect Stat High Sensitive Troponin-I
  • Modelo / Serial
    Reference: 3P25-25, lot 60103UI00 Reference: 3P25-26, lots 55946UI00, 58927UI00, 58927UI01,63010UI00Reference: 3P25-35, lot 59259UI00Reference: 3P25-36, lots: 55957UI00, 59904UI00, 62027UI00
  • Descripción del producto
    DETERMINATION OF THE DIFFERENT ANALYTS RELATED TO MUEESTRAS FROM THE HUMAN ORGANIZATION.
  • Manufacturer
    Importer: ABBOTT LABORATORIES DE COLOMBIA S.A.

Manufacturer

Importer: ABBOTT LABORATORIES DE COLOMBIA S.A.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA