Events

Alerta De Seguridad para Commercial name: cobas and 602 module - cobas 8000 Technical name: Physiological Fluid Analyzer ANVISA registration number: 10287410878 Hazard class: II

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
    2233
  • Fecha
    2017-03-17
  • 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
    Ensure that only pipes with a diameter of 13 to 16 mm are used in the cobas and 602 module. Replace any cobas® 8000 operator manual from version 5.0 with the new version 5.1, which states the correct non-standard pipe specifications. #### 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
    We would like to inform you that roche diagnostics gmbh, manufacturer of cobas® 8000 abroad, found a discrepancy between versions 4.2.1 and 5.0 of the cobas® 8000 operator's manual for non-standard tubes (tnps). version 5.0 of the operator's manual misleadingly indicates that tnps of 11 to 16 mm in diameter can be used in the cobas and 602 modules. however, only tnps with diameters of 13 to 16 mm are allowed for this module.
  • Acción
    Field Action Code SBN-CPS-2017-002 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Commercial name: cobas and 602 module - cobas 8000 Technical name: Physiological Fluid Analyzer A...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH