Events

Alerta De Seguridad para Name of the product: cobas® connection modules (CCM) - OUTPUT UNIT, accessory of the products under registration 10287411162 (cobas p512 and p612) Technical name: SAMPLE PROCESSOR ACCESSORY FOR HEALTH DIAGNOSIS ANVISA registration number: 10287411162 Hazard class: I Numbers Affected series: 20496176 204C5683 204C5684 204C5691 204C5692 204C5693 204C5694 204C5695 204C5700 (Roche stock) 204C5701 (Roche stock) 204C5702 (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
    2291
  • Fecha
    2017-05-17
  • 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
    If you identify that your unit is affected by rack vibration and samples are required for further processing, the unit should not be used until the Roche Diagnostica Brazil Field Service Representative performs the adjustment procedure. Potentially affected sample tubes should be disposed of in accordance with local regulations. An adjustment procedure that solves this problem is now available. All affected systems will be adjusted by a Field Service Representative from Roche Diagnostics Brazil.
  • Causa
    Roche diagnostics gmbh, a legal offshore manufacturer, has received a 5-position rack-related complaint on the output unit unit that was not being gently pushed into the tray and may cause rack vibration during sample transport, leading to possible spillage of the sample tube material.
  • Acción
    Field Action Code SBN-CPS-2017-008 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Name of the product: cobas® connection modules (CCM) - OUTPUT UNIT, accessory of the products und...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH