Events

Alerta De Seguridad para Product name: cobas® MPX Technical name: HIV, HBV AND HCV VIRUS NUCLEIC ACID ANVISA registration number: 10287411182 Hazard class: IV Affected model: 96 tests Serial numbers affected: 191957/195775

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda; Roche Diagnostics 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
    2313
  • Fecha
    2017-06-14
  • 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 INCQS was duly informed on this matter in case of need of action. There are no users / patients affected by this issue.
  • Causa
    Under specific conditions, there is a possibility that target-specific results sent to a customer's lis will not match the results displayed in the cobas® 6800/8800 systems user interface (ui). this applies to cobas® 6800/8800 systems software versions 01.01.09, 01.01.10 and 01.02.12. note: this action does not impact local users in brazil because it was not marketed in the country.
  • Acción
    Field Action Code SBN-RMD-2017-002 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will send informative.

Device

Product name: cobas® MPX Technical name: HIV, HBV AND HCV VIRUS NUCLEIC ACID ANVISA registration ...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH