Events

Alerta De Seguridad para Analyzers, laboratory, hematology, coagulation, Software for coagulation analyzer Behring Coagulation System Coagulation, model OV003, version 2.2

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Dade Behring Inc; Dade Behring GmbH.

¿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
    338
  • Fecha
    2001-11-16
  • 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
    The above software has a partially activated false-thromboplastin time period. the manufacturer initiated the correction by a letter dated 25 june 2001 from dade behring.
  • Acción
    Check receipt of letter dated June 25, 2001 from Dade Behring. The company claims that representatives have updated customer data files. For more information, please contact your local representative. ANVISA is interested in following if there has been good collaboration of the manufacturer | your laboratory. 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

Analyzers, laboratory, hematology, coagulation, Software for coagulation analyzer Behring Coagula...

Manufacturer

Dade Behring Inc; Dade Behring GmbH
  • Source
    ANVSANVISA