Events

Alerta De Seguridad para ADVIA Centaur BR Technical Name: ANTIGEN CA ANVISA Registration Number: 10345161849 Hazard Class: III Affected Model: 250 Test Kit / 50 Test Kit

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
    2269
  • Fecha
    2017-04-13
  • 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
    Siemens recommends discontinuing dilution of samples using ADVIA Centaur BR (CA 27.29) with Multi-Diluent 1 batches terminated at 2577 and future batches of Multi-Diluent 1 until further notice. The company does not recommend a review of the results previously generated.
  • Causa
    Siemens healthcare diagnostics has confirmed that the advia centaur br (ca 27.29) test does not linearly dilute when used with multi-diluent 1 batches 1 terminated at 2577 and to all future batches until a further notification. when diluted, some samples have a recovery greater than 120% from the expected pure value. the root cause of this problem is currently under investigation.
  • Acción
    Field Action Code CC 17-12 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

ADVIA Centaur BR Technical Name: ANTIGEN CA ANVISA Registration Number: 10345161849 Hazard Class:...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA