Events

Alerta De Seguridad para Preanalytical Equipment for Sample Management

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 Gmbh.

¿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
    I1703-86
  • Número del evento
    2015DM-0013314
  • Fecha
    2017-03-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=98
  • 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 when the referenced system uses disposable tips without a filter, the software can incorrectly calculate the depth of immersion, causing an aspiration of a greater number of clots, which could lead to delays in obtaining results from analysis carried out until the contamination of the samples.

Device

Preanalytical Equipment for Sample Management
  • Modelo / Serial
  • Descripción del producto
    The cobas 8100 preanalytic system and the p512 and p612 models is a modular unit interconnected with each other, for the processing and transport of patient samples in the clinical laboratory. The system has been designed to centrifuge patient samples, remove and insert the stoppers, apply barcode labels and with the pipettor prepare the aliquots from the primary samples. You can sort the samples online or off and temporarily store the samples. The system transports the different individualized samples between the analytical modules for immunology, blood chemistry, hematology, hormones, drugs, urine, coagulation and special for the respective laboratory analysis. The system does not report sample results values, it is not a sample analyzer.
  • Manufacturer
    Roche Diagnostics Gmbh

Manufacturer

Roche Diagnostics Gmbh