Events

Alerta De Seguridad para Product name: Accelerator 3600 Technical name: CELL PREPARATION / SAMPLING EQUIPMENT FOR IN VITRO DIAGNOSIS Anvisa Registration Number: 80146501830 Hazard Class: I Affected Model: Not applicable Affected serial numbers: ACP009

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil; Inpeco S.A..

¿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
    2171
  • Fecha
    2016-12-13
  • 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
    Customer Service or its representatives will visit the customer's location to replace the cables. Abbott will replace potentially non-compliant cables in the coming months. As parts are available, your Abbott service team will contact you to schedule replacement cables. Keep a copy of this statement in your lab files.
  • Causa
    Abbott diagnostics received the enclosed letter from inpeco, manufacturer of the accelerator a3600. you are receiving this notice because the products listed below may have been installed with a potentially non-compliant cable that could overheat. impacted specific cables connect the power distribution bus to the following modules: storage and retrieval module (srm) 9000; storage and retrieval module (srm) 15000; centrifuge module and i2000sr interface module.
  • Acción
    Field Action Code FA27OCT2016 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will make correction in the field.

Device

Product name: Accelerator 3600 Technical name: CELL PREPARATION / SAMPLING EQUIPMENT FOR IN VITRO...

Manufacturer

Abbott Laboratórios do Brasil; Inpeco S.A.
  • Source
    ANVSANVISA