Events

Alerta De Seguridad para VISIT PREGNANCY. Anvisa Registry No. 10350840127. Products under risk in Brazil: Lot 13052 (expiry 01/31/2015), lot 13053 (expiry 01/31/2015) and lot 13057 (expiry 05/31/2015).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIOSYS LTDA; OMEGA DIAGNOSTICS LTDA.

¿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
    1300
  • Fecha
    2013-10-03
  • 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
    The company is collecting batches at risk due to complaints received, related to obtaining false-positive results with the product in question. The retention samples in the manufacturer did not show the deviation, however the company is preventively collecting the product and is investigating the cause of the problem. Access to the Company Alert Message: http://portal.anvisa.gov.br/wps/wcm/connect/362e3b004152ff89a58fafa8d08ea2d4/Carta_de_Recall_aos_clientes.pdf?MOD=AJPERES
  • Causa
    Possibility of occurrence of false-positive results higher than expected for the product.
  • Acción
    Lots under risk will be collected by the registry holder. Identify and segregate the products at risk in your inventory and contact Biosys Ltda for return.

Device

VISIT PREGNANCY. Anvisa Registry No. 10350840127. Products under risk in Brazil: Lot 13052 (expir...

Manufacturer

BIOSYS LTDA; OMEGA DIAGNOSTICS LTDA
  • Source
    ANVSANVISA