Events

Alerta De Seguridad para Dimension RxL Biochemical Analyzers with RxL / HM software version 5.1

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.

¿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
    332
  • 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 analyzers give incorrect and low results for a number of patient samples. the distributor started the removal by letter dated april 9, 2001.
  • Acción
    Check receipt of the letter dated 9 April 2001 from Dade Behring. The company claims that it provided consumers with updated Dimension RxL software with version 5.1.1 on April 17, 2001. For more information, contact your local representative. ANVISA is interested in following if there was good collaboration of the distributor with its 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

Dimension RxL Biochemical Analyzers with RxL / HM software version 5.1

Manufacturer

Dade Behring Inc
  • Source
    ANVSANVISA