Events

Alerta De Seguridad para Vitek 2 GN Cards - Identification of gram negatives.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomerieux 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
    1416
  • Fecha
    2014-08-26
  • 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
    Fill out and send the Kis Recall Notification form for withdrawal and replacement of the product. Access Security Card at: http://portal.anvisa.gov.br/wps/wcm/connect/b2e1558045699635840fc4e23d5c835b/Carta+Seguran%C3%A7a_Biomerieux.pdf?MOD=AJPERES
  • Causa
    A nonconformity was detected on the vitek 2 gn - identification card for gram negative, when some escherichia coli isolates were tested. it was determined that for the aglu substrate, some false positives may occur for some strains of escherichia coll, causing an incorrect identification of e. coli isolates, such as serratia fonticola.
  • Acción
    Ensure that the guidance letter has been dis- tributed and reviewed for all appropriate personnel within the organization. Analyze your current inventory of caths 2 Negative Gram Identification. If you still have Kits of the affected product (Ref. 21341, Lot 241289140), discontinue use of the same and contact the Customer Service of Biomerieux for collection and replacement of the product.

Device

Vitek 2 GN Cards - Identification of gram negatives.

Manufacturer

Biomerieux Inc.