Events

Alerta De Seguridad para Immulite 2000 Immunoassay System, registration 10345161777 ///// Immulite 1000 System, registration 10345160643 /// Immulite 2000 System, registration 10345160645 /// Immulite Immunoassay System 10345161653. The identification of the affected products are listed in the Chart in Attachment.

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
    1636
  • Fecha
    2015-07-10
  • 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
    According to the holder due to the problem in the conductive material, measurement errors may occur at the level even though there is the minimum volume of sample present in the sample cup or tube. . An error message may appear if there is not enough sample in the microsample tube or sample cup
  • Causa
    The conductive material of the immulite / immulite 1000 sample cup holders and the immulite 2000 / immulite 2000xpi microsample inserts, both used for sample processing, do not meet the specification to facilitate measurement of the liquid and sample level respectively (sensor error). level).
  • Acción
    According to the holder of the registration, for IMMULITE / IMMULITE 1000 the problem can be solved by adding more sample to the sample cup. For IMMULITE 2000 / IMMULITE 2000XPi the problem can be solved by adding more sample to the micro-sample tube. The company will make a field correction of the analyzers with replacement of the units. See affected lots in the ANNEX. Upon receiving the new sample cup Holder or microsample insert discard the products from the problematic lots.

Device

Immulite 2000 Immunoassay System, registration 10345161777 ///// Immulite 1000 System, registrati...

Manufacturer

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