Events

Alerta De Seguridad para ARCHITECT i Septum

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Loboratórios do Brasil - Divisão Diagnósticos.

¿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
    793
  • Fecha
    2004-08-24
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    It is important to note that this situation occurred only for the ARCHITECT i TESTOSTERONE Reagent LN 6C28-20 and 6Cc28-25 assay, and was not observed for the other assays of the ARCHITECT line. Currently in Brazil, the ARCHITECT TESTOSTERONA Reagent, is not being marketed. If you have questions about the information contained in this release, please call the Customer Service Center, Tel .: 0800-11-9099.
  • Causa
    The abbott diagnostics division determined that the current architect i septum n ° list: 4d18-01, when used in conjunction with the architect assay. testosterone reagent ln 6c28-20 and 6cc28-25 could generate a contamination. this would be possible because of this contaminant present in the current architect i septum n ° list: 4d18-01, have similar chemical structure and compete with testosterone binding sites. with the new architect i septum n ° list: 4d18-02, this contaminant has been eliminated.
  • Acción
    Reconstruction of ARCHITECT i Septum. The new ARCHITECT i Septum N ° List: 4D18-02 is being replaced by the current ARCHITECT i Septum N ° List: 4D18-01, used with all ARCHITECT assays. The new ARCHITECT i Septum N ° List: 4D18-02 can be identified by the white color of the package instead of the actual green color ARCHITECT i Septum List Nr .: 4D18-01.

Device

ARCHITECT i Septum

Manufacturer

Abbott Loboratórios do Brasil - Divisão Diagnósticos
  • Source
    ANVSANVISA