Events

Alerta De Seguridad para COBAS P 512 PRE-ANALYTICAL SYSTEM Technical name: Instrument for the preparation and processing of samples - preanalytical phase ANVISA registration number: 10287411162 Hazard class: I Serial numbers affected: 64002616; 64002716; 64002816; 64002916; 64003016; 64003116; 64007017 (Roche stock)

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
    2312
  • Fecha
    2017-06-12
  • 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
    Verify that the Rotate Status Detection feature is used in accordance with the updated Operator's Manual. (update described in the field action notification letter).
  • Causa
    Roche diagnostics gmbh, manufacturer of the product, initiated this field action as it identified opportunities for improvements in the detection of rotation and re-labeling of the cobas p 512 pre-analytical system upon receipt of complaints from two customers reporting that non-standard samples - centrifuges were incorrectly identified as "centrifuged" by detecting the rotation state in the cobas p 512 (64x) preanalytic system. in investigating such complaints, roche diagnostica has identified that all documentation related to the state of rotation detection needs to be updated to reflect the correct use intended.
  • Acción
    Field Action Code SBN-CPS-2017-010 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

COBAS P 512 PRE-ANALYTICAL SYSTEM Technical name: Instrument for the preparation and processing o...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH