Events

Alerta De Seguridad para TROMBO ISI - ANVISA Record N ° 10158120102

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomerieux Brasil S.A.

¿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
    803
  • Fecha
    2005-04-14
  • 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
    Verify that you received the letter from Empresa Biomérieux Brasil SA, requesting the non-use of the product, until the collection of the table with the correct values. Identify and isolate any affected product in your inventory. For more information, contact your local representative or your own company by calling 0800264848. For further information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone ( 61) 448-1485.
  • Causa
    Occurrence of error during transcription of inr value - for a time of 20.9 seconds and a reference time of 11.0 seconds, the inr is 3.85 and not 6.85.
  • Acción
    The company decided to inform its customers immediately of not using the product, until the collection of the table with the correct values. Block the marketing of the product, and adjust the corrected table in the Blocked Kits.

Device

TROMBO ISI - ANVISA Record N ° 10158120102

Manufacturer

Biomerieux Brasil S.A
  • Source
    ANVSANVISA