Events

Alerta De Seguridad para MOLECULAR FAMILY HLA SSO. Several products (see full description at: http://portal.anvisa.gov.br/wps/wcm/connect/745a4300466363a88801bf0ce2062da6/comunicacao_aos_+usuarios.pdf?MOD=AJPERES) ... Anvisa Registration No. 1035890014.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Invitrogen Ltd.; Life Technologies Brasil Com. e Ind. de Produtos para Biotecnologia Ltda..

¿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
    1053
  • Fecha
    2011-04-05
  • 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
    All batches of the mentioned products are affected, according to the record holder. The company said it is already collecting the products at risk.
  • Causa
    Aged oligonucleotides used in probes and primers may present stability related problems.
  • Acción
    Examine your inventory and discontinue use of the product immediately if you have products at risk. All identified affected products should be returned to the record holder, following instructions available at http://portal.anvisa.gov.br/wps/wcm/connect/745a4300466363a88801bf0ce2062da6/comunicacao_aos_+usuarios.pdf?MOD=AJPERES. Tests already carried out using products at risk should be repeated using alternative methods.

Device

MOLECULAR FAMILY HLA SSO. Several products (see full description at: http://portal.anvisa.gov.br/...

Manufacturer

Invitrogen Ltd.; Life Technologies Brasil Com. e Ind. de Produtos para Biotecnologia Ltda.
  • Source
    ANVSANVISA