Events

Alerta De Seguridad para Enzygnost® Anti-VZV / IgG - Registration number: 10345161685 - Risk class II (Products of medium risk to the individual and / or low risk to public health, subject to registration) - Lots: 44218; 44309; 44565; 45077.

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 PRODUCTS GMBH.

¿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
    1695
  • Fecha
    2015-10-22
  • 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 recommends discontinuing the use of the Enzygnost Anti-VZV / IgG product.
  • Causa
    Lots 44309; 44565; 45077 of the enzygnost anti-vzv / igg product may exhibit a greater variation of homogeneity. this can lead to invalid races because they do not meet the p / n reference validation criteria at the beginning and end of the series. this issue may lead to an underestimation of the immunity status measured by the titration levels as the absorbance values ​​of samples with falsely low results. the risk of false negative results is unlikely but can not be totally excluded. when monitoring a potential infection by changing the title level over time with repeated design, the variance of the levels may be higher than expected. in rare cases, this can lead to a title change.
  • Acción
    The company that holds the registration is promoting the "Discontinuation of use" of the product. (Attached Letter to Clients). PI Code 15-019.

Device

Enzygnost® Anti-VZV / IgG - Registration number: 10345161685 - Risk class II (Products of medium ...

Manufacturer

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