Events

Alerta De Seguridad para Immunoassay Analyzer CENTAUR

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 Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing 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
    I1705-188
  • Número del evento
    2015DM-0013041
  • Fecha
    2017-05-31
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=84
  • 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 due to multiple software problems could affect the operation and workflow of the referenced medical devices, causing unprocessed tubes, malfunction of the lis system (information system), it may also generate some of the following error messages "unknown status "," no primary ", this could lead to errors and delays in the processing of the samples.

Device

Immunoassay Analyzer CENTAUR
  • Modelo / Serial
  • Descripción del producto
    The ADVIA CENTAUR XPT SYSTEM is an automated analyzer instrument for continuous random access continuous chemiluminescence immunoassay testing. Use of urine, serum or plasma samples for in vitro diagnostic tests (IVD) of the groups of trials include those of fertility, thyroid function, oncology, cardiovascular, anemia, determination of therapeutic drugs, infectious diseases, allergy, adrenal and metabolic function. It is in automated system that reports the values of the tests and communicates the results of clinical of the patient. XPT system is of high efficiency and performance for specialized and routine tests in the clinical laboratory.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing Ltd

Manufacturer

Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing Ltd
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA