Events

Alerta De Seguridad para cholesterol FS- Ref.11350, 11300

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 manufacturer #121.

¿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
    IRD-020715
  • Número del evento
    2007RD-0000328 ; 2007RD-0000327 ; 2007RD-0000329
  • Fecha
    2015-07-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=176
  • 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
    Assays using the trinder reaction may generate incorrect results in samples containing n-acetylcysteine (nac), paracetamol and metamizole. trinder-based assays using a colorimetric reaction between hydrogen peroxide, a phenol derivative and aminoantipyrine catalyzed in the presence of peroxidase, can be altered by some medications, causing falsely low results.

Device

cholesterol FS- Ref.11350, 11300
  • Modelo / Serial
    CHOLESTEROL FS- Ref.11350, 11300 CREATININA PAF FS – Ref. 11759GLUCOSA GOD FS – Ref. 1 2550, 12500HDL-C SELECT FS- Ref. 1 3521LDL-C SELECT FS Ref.1 4121TRIGLYCERIDES FS- Ref.1 5760, 1 5710
  • Descripción del producto
    Quantitative in vitro determination of the related analytes in serum or plasma of samples from the human body
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • 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