Events

Alerta De Seguridad para AxSYM hTSH Ultrasensitive II Calibrator.

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

¿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
    905
  • Fecha
    2008-03-25
  • 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 user must respond to the Customer Response Form sent to the customers involved with the problem. Abbott is performing the product exchange and the replacement performed by the company will be based on the information provided in the response form (for more information, contact Abbott at 0800-11-9099).
  • Causa
    When using the axsym htsh ultrasensitive ii calibrator (list no. 7b39-20) near the expiration date, some users may experience an increased frequency in high control results in addition to the upper control range. abbott verified the occurrence only with high control.
  • Acción
    You should review your inventory and, if you find products with lot numbers 52369Q100 and 53620Q100, you should discontinue use (if in use) and separate them for later return to Abbott.

Device

AxSYM hTSH Ultrasensitive II Calibrator.

Manufacturer

Abbott Laboratories
  • Source
    ANVSANVISA