Events

Alerta De Seguridad para ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT

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 ABBOTT GMBH & CO. KG CON DOMICILIO EN || ALEMANIA. || Imported by: 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
    RRD-031216
  • Número del evento
    INVIMA 2011RD-0002106
  • Fecha
    2016-12-12
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=110
  • 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 problem of specific stabilities of the reagent lots 10533up00 and 10535up00. as the reagent approaches the expiration date, the values in relative units of light (url) of the calibration curve decrease, causing the results of patients calculated with this diminished curve to rise excessively, resulting in false patient results. the controls may not reflect the instability of the reactive, since the recalibration can make the values of the controls are within the acceptable ranges.

Device

ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT

Manufacturer

ABBOTT GMBH & CO. KG CON DOMICILIO EN || ALEMANIA. || Imported by: ABBOTT LABORATORIES ...
  • 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