Events

Alerta De Seguridad para COBAS 6800/8800 SYSTEMS analyzers

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 || Roche Diagnostics International Ltd..

¿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
    I1609-372
  • Número del evento
    2015DM-0013313
  • Fecha
    2016-09-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=123
  • 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 states that it has detected that it has detected the possibility of a sample sub-aspiration occurring when the application configuration requests sample volumes below 450μl, caused by foam or bubbles in the sample tube, leading to false presentations. results or results without alarms, generating adverse events on patients.

Device

COBAS 6800/8800 SYSTEMS analyzers
  • Modelo / Serial
    Cobas 6800, specific serials.
  • Descripción del producto
    The COBAS 6800/8800 SYSTEMS analyzers use an integrated and automated workflow for the analysis of nucleic acids (NAT) based on the polymerase chain reaction (PCR) in order to apply them in diagnostic laboratories and blood tests. The COBAS 6800/8800 SYSTEMS combine the functionalities of instrumentation, consumables, reagents and data management to provide an efficient workflow from sample processing to interpretation of results. This technology applies to any type of NAT test by PCR for health, industry, research, teaching and phytosanitary.
  • Manufacturer
    Roche Diagnostics Gmbh || Roche Diagnostics International Ltd.

Manufacturer

Roche Diagnostics Gmbh || Roche Diagnostics International Ltd.