Events

Alerta De Seguridad para ONETOUCH ULTRA REAGENT STRIP for determination of blood glucose concentration. ANVISA REGISTRY: 80145900869.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por JOHNSON & jOHNSON PRODUTOS PROFISSIONAIS LTDA; LIFESCAN SCOTLAND LTD.

¿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
    879
  • Fecha
    2007-07-16
  • 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
    According to the company that holds the product registration in Brazil (Johnson & Johnson Produtos Profissionais Ltda.), No complaints or product returns have been reported in Brazil to date due to the mentioned effect. Globally, the cited defect was found in eight (8) product units, out of a total of 53,000,000 (fifty-three million) units distributed globally.
  • Causa
    Some product units may have a hole in the side of the bottle. this type of problem may allow air or moisture to enter the vial, which would damage the reagent strips and cause incorrect glucose readings.
  • Acción
    Customers should not use reagent strips of products whose vials have holes in the side, under risk of incorrect reading of the blood glucose concentration. In these cases, the company that owns the registration in Brazil (Johnson & Johnson Produtos Profissionais Ltda.) Must be contacted by phone 0800-7015433.

Device

ONETOUCH ULTRA REAGENT STRIP for determination of blood glucose concentration. ANVISA REGISTRY: 8...

Manufacturer

JOHNSON & jOHNSON PRODUTOS PROFISSIONAIS LTDA; LIFESCAN SCOTLAND LTD
  • Source
    ANVSANVISA