Events

Alerta De Seguridad para Coagulation Analyzer for PT and INR

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 Plexus Manufacturing Sdn. Bhd. || Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Product Gmbh || Universal Biosensor Pty 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
    I1609-379
  • Número del evento
    2015DM-0013131
  • Fecha
    2016-09-08
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=122
  • 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 it has detected a defect in the software in the referenced system due to failures in the calibration of the testpak and the status of the quality control (qc), which could lead to potential delays in the processing of the samples.

Device

Coagulation Analyzer for PT and INR
  • Modelo / Serial
    Stratus CS 200, all serials.
  • Descripción del producto
    The coagulation analyzer for PT and INR XPRECIA STRIDE is designed to be used by professional healthcare personnel and / or appropriately trained patients, to perform the quantitative determination of the time of the thromboembolism (PT) and the standardized INR index for the control of oral anticoagulant therapy conwarfarin , antagonist of vitamin k, within the intrinsic system of coagulation. The system uses the total capillary blood freshly extracted (by digital puncture) from the patient and is measured through the test strips designed for PT and INR.
  • Manufacturer
    Plexus Manufacturing Sdn. Bhd. || Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Product Gmbh || Universal Biosensor Pty Ltd

Manufacturer

Plexus Manufacturing Sdn. Bhd. || Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagn...
  • Source
    NIDFSINVIMA