Events

Alerta De Seguridad para Reagents, microbiology, control. Control sera for laboratory test kits for venereal disease research. catalog number 235201; Number of lots: 149027LA, 149484LA

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BD Diagnostic Systems.

¿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
    320
  • Fecha
    2001-11-02
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Sera from weakly reactive controls from venereal disease research laboratories (vdrl) demonstrated comparable reactivity to, or stronger than, vdrl positive control sera. the exacerbated and unexpected reactivity of this control invalidates the assay and the user can not qualify the antigen suspension. the manufacturer commenced removal by letter dated june 2001.
  • Acción
    Verify receipt of a letter dated June 2001 from BD Diagnostic Systems. Identify and isolate all affected products in your inventory. For more information, please contact your local representative. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Reagents, microbiology, control. Control sera for laboratory test kits for venereal disease resea...

Manufacturer

BD Diagnostic Systems
  • Source
    ANVSANVISA