Events

Alerta De Seguridad para Cobas® HIV-1 and HBV Technical Name: ANVISA Registration Number: Hazard Class: IV Model Affected: Registries: 10287411153 and 10287411154 Serial Numbers Affected: 1) cobas® HIV-1 Test (6979599190) Lot W11636 2 ) cobas® HBV Test (6979564190) Lot W14007

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
    2224
  • Fecha
    2017-02-22
  • 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 INCQS has been duly informed on this issue in case there is a need for action. There are no users / patients affected by this issue. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    Roche diagnostica brasil has received from its overseas manufacturer (roche diagnostics gmbh) a statement regarding the results of the cobas® hiv-1 and cobas® hbv tests used in the cobas 4800 system and, therefore, shares the information only for information, since brazil did not import these batches for use in clinical laboratories. the tests were all used for analysis and validation in incqs (national institute of health quality control) and there is no risk of release of results for patients. field action title: potential false negative result with the cobas® hiv-1 and cobas® hbv tests for use in the cobas 4800 system.
  • Acción
    Field Action Code SBN-RMD-2016-024 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make information.

Device

Cobas® HIV-1 and HBV Technical Name: ANVISA Registration Number: Hazard Class: IV Model Affected:...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH