Alerta De Seguridad para Trade name: ADVIA Centaur Cyclosporin (CsA); ADVIA Centaur DHEA-SO4 (DHEAS); ADVIA CENTAUR FOL; ADVIA CENTAUR HBc IgM-. Technical Name: Ciclosporin; Dehydroepiandrosterone Sulfate (Dhea-S); Folate. Nuclear Immunoglobulin M for Hepatitis B Virus. ANVISA registration number: 10345161772; 10345161738; 10345160571; 10345160594. Class of risk: III; II; II; IV. Model Affected: N / A. Serial number affected: See distribution map

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos Ltda; Siemens Healthcare Diagnostics Inc..

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    The probability of misinterpretation of the results for the above tests due to this problem is remote. Mitigations include correlation with clinical history and presentation of other laboratory diagnostic tests and / or serial tests, depending on the analyte. Siemens does not recommend a review of past results because of this problem. Users and customers should consult the information provided in the Notification Letter until the updates to the instructions for use (IFU) regarding biotin interference are completed. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link;;; Additional information: - Date of identification of the problem by the company: 02/01/2018 - Date of entry of the notification to the Anvisa: 02/01/2018 The company holding the record of the affected product is responsible for timely contacting its clients in order to guarantee the effectiveness of the Field Action in progress.
  • Causa
    Siemens healthcare diagnostics has confirmed through internal investigations that the advia centaur system trials listed in annex 1 - product data are susceptible to biotin interference. this occurs when the biotin-present in patient samples interferes with the assay biotin-streptavidin architecture on the advia centaur platforms. the concentrations of biotin listed in the interferences section of the current directions for use (ifu) for cyclosporine (csa) and dhea-so4 (dheas) of the advia centaur systems do not correctly reflect their levels at which biotin causes a bias ≤10%. the current instructions for use (ifu) for folate (fol) and hbc igm (ahbcm) of the advia centaur systems do not list biotin in the interferences section.
  • Acción
    Field Action Code CC 18-05 triggered under the responsibility of Siemens Healthcare Diagnósticos Ltda. Customer Service