Events

Alerta De Seguridad para Tina-quant hBa1c Gen 2

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 ROCHE DIAGNOSTICS MANNHEIM GMBH || Imported by: PRODUCTOS ROCHE 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
    IRD-011016
  • Número del evento
    INVIMA 2016RD-0003782
  • Fecha
    2016-10-04
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=119
  • 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 health agency notifies, that roche diagnosticsmannheim gmbh "(...) reports that it has identified a possible high recovery in the qc materials and patient samples, in all batches of the reagent related in the upper part of the report, after being appropriately stored below the 0 ° c ", likewise manifests that" (...) the internal investigation carried out by our housekeeper defined that the definitive cause is unknown. investigations assume that unintentional storage at low temperatures even below 0 ° c in the client, or during transport, could cause the formation of precipitates in the antibody reagent, which leads to falsely elevated results ".

Device

Tina-quant hBa1c Gen 2

Manufacturer

ROCHE DIAGNOSTICS MANNHEIM GMBH || Imported by: PRODUCTOS ROCHE S.A.