Events

Alerta De Seguridad para AxSYM CA15-3 MASTER Calibrator no. List 3B42-30, Lot no. 86504M300. CA15-3 STANDARD Calibrator no. List 9C08-01, Lot no. 88127M100, Reg. Anvisa no. 10055311039

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
    712
  • Fecha
    2003-03-28
  • 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 informs: That it is conducting research to determine the cause. The supply is standardized as other batches of CA 15-3 gauges were unaffected and available in stock. Any questions please contact the Customer Service Center (0800-119099).
  • Causa
    Abbott laboratories - dignity division has identified that calibrators ca 15-3 (axsym ca15-3 master calibrator no. list 3b42-30, lot no. 86504m300 ca15-3 standard calibrator no. list 9c08-01, lot no. 88127m100) may cause a decrease of values ​​for the ca15-3 high control and for patient samples. these lower values ​​can have the following effects: - there is possibility of obtaining lower or out of control values ​​of the instructions for use, causing an invalid test.- patient results can be decreased by about 6.5 - 7.4 %. this small change should not affect patient management.
  • Acción
    -Identify if there is in your stock the said product. - Discontinue use of these. -Preply the response protocol, for later return and bonus of the product. -Recall the CA 15-3 test using a different calibrator batch. -You may need to re-establish control strips when using a new batch of calibrators.

Device

AxSYM CA15-3 MASTER Calibrator no. List 3B42-30, Lot no. 86504M300. CA15-3 STANDARD Calibrator no...

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA