Events

Alerta De Seguridad para Trade name: ADVIA CENTAUR CA 19-9 Technical name: ANTIGEN CA 19-9 Registration number ANVISA: 10345161747 Hazard class: III Affected model: Kit for 50 tests; 250 test kit Serial numbers affected: 94990382, 39741386, 51303388, 82030380, 86322380, 6712382, 39742386, 48671388, 51673388, 60175390, 33687386, 80293380, 87147380

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC.

¿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
    2083
  • Fecha
    2016-11-18
  • 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
    For clients who use the CA 19-9 trial in the ADVIA Centaur CP and ADVIA Centaur / XP / XPT systems alternately, a review of patient outcomes generated over the past three months is recommended. Customers should not use the ADVIA Centaur XP / XPT and ADVIA Centaur CP Systems together to generate CA 19-9 results for patient monitoring. Serial patient monitoring can continue as long as the system is used independently.
  • Causa
    The advia centaur cp assay ca 19-9 does not meet the correlation with the ca 19-9 assay of the advia centaur / xp / xpt systems as mentioned in the instructions for use. advia centaur cp generates lower results for patient samples. correlation and bias between systems can be verified in customer notification. with quality control material and external quality assessment material, customers may observe a bias in which the results of the ca 19-9 advia centaur cp test are higher than the results of the ca 19-9 advia centaur / xp / xpt.
  • Acción
    Field Action Code CC 16-02 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: ADVIA CENTAUR CA 19-9 Technical name: ANTIGEN CA 19-9 Registration number ANVISA: 103...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA