Alerta De Seguridad para VES STATIC Model LIHD 140; Semi-Automatic Bio Chemistry Analyzer SCREEN MASTER TOUCH; UR-800 Stripper Processor URINE AUTOMATIC ANALYZER; Biochemical Analyzer MEGA 200; and ESR Mouse. All units in the market.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por B4B LATINO AMERICA PRODUTOS HOSPITALARES 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
    1219
  • Fecha
    2012-12-28
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    Anvisa determined, through Resolution RE No. 4,842 of 11/12/2012, as a measure of sanitary interest, the suspension, throughout the national territory, of the importation, disclosure, distribution, sale and use of all lots of the products "VES STATIC model LIHD 140", "Semi-Automatic Bio Chemistry Analyzer SCREEN MASTER TOUCH", "UR-800 URINE AUTOMATIC ANALYZER STRIP PROCESSOR", "MEGA 200 Biochemical Analyzer" and "ESR MOUSE" imported by company B4B Latin America Products Hospitalares Ltda (CNPJ: 08.279.163 / 0001-67), with address at Avenida Gomes Freire, nº647, room 605 - Centro - Rio de Janeiro - RJ, because they do not have an Anvisa registry. Anvisa, through the aforementioned RE, also determined the payment of all units of the products mentioned on the market.
  • Causa
    Commercialization of health products without registration at anvisa.
  • Acción
    Collection of all units on the market of the products mentioned.

Manufacturer