Events

Alerta De Seguridad para Technopath Multichem IA Plus, registration: 80146501893, Class of Risk: III - high risk product to individual and / or medium to public health, serial number / lot: 33505140.

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 LTDA.; TECHNO-PATH MANUFACTURING LTDA..

¿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
    1560
  • Fecha
    2015-04-02
  • 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 stability specifications of the opened bottle in the Instructions for Use written in Portuguese do not apply to lot 33505140.
  • Causa
    02 problems were recorded: incorrect instruction resulting in an error in the stability specifications of the open bottle; the process of suitability was carried out outside the appropriate temperature conditions, i.E. at a temperature of -20 ° c or below. the consequence of subjecting the product to a partial freeze-thaw cycle is the change in its performance.
  • Acción
    The registration holder advises customers to discontinue use of the product in accordance with laboratory procedures and forward letter to the company to arrange for the product to be collected.

Device

Technopath Multichem IA Plus, registration: 80146501893, Class of Risk: III - high risk product t...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA.; TECHNO-PATH MANUFACTURING LTDA.
  • Source
    ANVSANVISA