Events

Alerta De Seguridad para Trade name: Kit Nat HIV / HCV / HBV Bio-Manguinhos ///. Technical Name: HIV VIRUS NUCLEIC ACID, HBV AND HCV ///. ANVISA registration number: 80142170025 ///. Risk class: IV - High Risk ///. Number of batches affected: 14ONT040Z; 14ONT042Z; 152NB009Z; 155NB031Z; 155NB033Z

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Fundação Oswaldo Cruz.

¿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
    2013
  • Fecha
    2016-10-27
  • 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 company, samples used in external quality control tests (CQE) obtained from the American College of Pathology (CAP), are not suitable for evaluations of product performance, since some variables can contribute to the results are not compatible with those specified in the manual.
  • Causa
    Report of unsatisfactory results in external quality control (cqe) tests obtained from the american college of pathology (cap) for bio-manguinhos / fiocruz nat kit / hcv / hbv kits.
  • Acción
    Field Action Code 201610001 triggered under the responsibility of the company Oswaldo Cruz Foundation. Company will correct the instructions for use.

Device

Trade name: Kit Nat HIV / HCV / HBV Bio-Manguinhos ///. Technical Name: HIV VIRUS NUCLEIC ACID, H...

Manufacturer

Fundação Oswaldo Cruz