Events

Alerta De Seguridad para Coagulation 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 Sysmex Corporation || Sysmex Corporation Kakogawa Factory.

¿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
    I1702-60
  • Número del evento
    2010DM-0005612
  • Fecha
    2017-02-20
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=101
  • 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 has confirmed that, in very rare circumstances, a false negative result for the innovance d-dimer assay may be reported by the referenced devices, as a result of an antigen overflow error that triggers an automatic re-reading of 1/19 and the unprocessed signal the reading is lower than the white limit method (lob), leading to alterations in the result.

Device

Coagulation Analyzer
  • Modelo / Serial
  • Descripción del producto
    The coagulation analyzers CS2000I / CS2100I are fully automated instruments for quantitative decoagulation tests by coagulometry, immunological and chromogenic. Continuous random access. Uses plasma samples for in-vitro diagnostic tests (IVD) of PT, APTT, TT, fibrinogen, D-Dimero, AT-III; PLG; PC and individual factors I to XIII. It is in an automated system that reports the values of the tests and communicates the results of the patient's clinicians. The reagents that are used with the SYMEX CS2000I / CS2100I equipment have their respective health records.
  • Manufacturer
    Sysmex Corporation || Sysmex Corporation Kakogawa Factory

Manufacturer

Sysmex Corporation || Sysmex Corporation Kakogawa Factory
  • Empresa matriz del fabricante (2017)
    Sysmex Corp.
  • Source
    NIDFSINVIMA