Events

Alerta De Seguridad para Immunoglobulin E Test Kit, Catul-Specific Immulite Radioallergosorbent, Model LKE11 115

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

¿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
    400
  • Fecha
    2002-02-22
  • 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
    In the above test kits, components, the beads (bead components), may be missing, resulting from improper packaging. the manufacturer initiated a telephone and fax removal on 31 october 2001.
  • Acción
    Verify that you received the call or fax on 31 October 2001 from Diagnostic Products. Identify and isolate any affected product in your inventory. For more information, contact Diagnostic Products by phone at (1310) 645-8200, or contact your local representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Immunoglobulin E Test Kit, Catul-Specific Immulite Radioallergosorbent, Model LKE11 115

Manufacturer

Diagnostic Products Corp
  • Source
    ANVSANVISA