Events

Alerta De Seguridad para Name of the product: ADVIA CENTAUR TnI ULTRA /// Record number: 10345160531 /// Affected: 100 tests - lots: 24483099; 28137099; 36527099; 4,251,6099; 46626101; 5,965,5103; 53539104; 72936105; 81676105; 89385106; 94642106. 500 tests - Batches: 24479099; 26294099; 4,320,5101; 46929101; 5,780,5103; 65432103; 52590104; 73322105; 80480105; 86319106; 94250106 / / / Product hazard class: II.

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
    1920
  • Fecha
    2016-06-28
  • 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
    This problem is not expected to impact the diagnosis or treatment. The ability of the assay to detect the decrease or serial increase of TnI-Ultra will not be impacted; therefore, it is not necessary to review the results of previous tests or to perform repeated tests of the previously reported results.
  • Causa
    Siemens healthcare has forwarded to anvisa the cc 16-12 field action stating that the advia centaur tni ultra product exhibits a greater than 10% change in results from samples with biotin levels greater than 10 ng / ml (41 nmol / l) .
  • Acción
    Field Classification: Letter to the Client /// Field action code: CC 16-12 /// Recommendations to users and patients: continue to use the TnI-Ultra ADVIA Centaur assay. Be careful of patients taking biotin supplements that may exhibit a small increase in TnI-Ultra results; however, the ability of the assay to detect the increase or decrease in TnI is maintained.

Device

Name of the product: ADVIA CENTAUR TnI ULTRA /// Record number: 10345160531 /// Affected: 100 tes...

Manufacturer

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