Events

Alerta De Seguridad para TOSOH G7 HPLC automated system analyzer

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.

¿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
    I1703-94
  • Número del evento
    2009DM-0004739
  • Fecha
    2017-03-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • 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 reports that the referenced medical devices can give hba1c values with a negative bias for patients with variants of hemoglobin c, d, e and s with higher levels of hba1c (for example, 9%), but not at the level of medical diagnosis. 6.5%, which could lead to delays in the processing of samples.

Device

TOSOH G7 HPLC automated system analyzer
  • Modelo / Serial
  • Descripción del producto
    The TOSOH G7 HPLC automated system analyzer is a fully automated high-performance liquid chromatography instrument that rapidly and precisely separates hemoglobins found naturally in the blood. Glycosylated hemoglobins and other components of hemoglobin are extracted depending on the charge of the molecule in relation to an incremental gradient that pass through a non-porous cationic column. In the mode of HbA1c variant analysis, the predetermined windows are configured in the software to detect the presence of HbA1a, HbA1b, HbF, labile HbA1c (la1c), HbA1c (sa1c), and a0. The reagents that are used with the TOSOH G7 analyzers have a respective health record.
  • Manufacturer
    Tosoh AIA

Manufacturer

Tosoh AIA
  • Empresa matriz del fabricante (2017)
    Tosoh Corp.
  • Source
    NIDFSINVIMA