Events

Alerta De Seguridad para CONTROL OF THREE LEVELS 26 Reg. No. 10055310742, no. List 1H71-01, lot no. CD053,

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL 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
    736
  • Fecha
    2003-07-18
  • 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
    Check if there are any batches in your stock. If you do, please contact ABBOTT LABORATORIOS DO BRASIL LTDA, by telephone 11 5367000 or your local representative, in order to make the return and consequently the replacement of the same.
  • Causa
    Low parameter recovery for three level control 26, lot no. cd053. none of the other parameters is affected. in research, cell-dyn 1700, cell-dyn 3200, cell-dyn 3700/3500 and cell-dyn 4000 systems (both optical parameters for platelets and impedance parameters for platelets) were observed.
  • Acción
    This occurrence is still under investigation. Until the present date, viscous platelets had been identified as the most probable cause (06/26/2003).

Device

CONTROL OF THREE LEVELS 26 Reg. No. 10055310742, no. List 1H71-01, lot no. CD053,

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA