Alerta De Seguridad para i-sens Model CareSens II

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por i-SENS Inc.

¿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
  • Fecha
    2009-04-23
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Press release
  • Causa
    Recall of blood glucose meters with incorrect readings (i-sens model caresens ii) the department of health today (april 23) alerted the public and the medical sector, of a voluntary recall of a type of blood glucose meter (bgm)which displayed falsely low readings. dh immediately looked into the case upon receiving notification from an informant that two bgm manufactured by i-sens inc, were found to display falsely low readings. it was revealed that only one specific lot (lot no. isp11e02101 – isp11e02600) of the bgm was affected. the manufacturer, i-sens inc, has initiated a voluntary recall through its distributor, bioscan ltd. according to bioscan ltd, there were 150 bgm of the affected lot imported to hong kong and 106 bgm to macao respectively. dh has notified the health bureau of macao of the recall. users should not use the blood glucose meters of the affected lot and seek advice from their doctors. the department has not received any report of adverse events arising from this issue. dh will closely monitor the recall. the spokesman said people using the meters concerned should contact the company by calling its hotline (3589 6670) during office hours for replacement. ends/thursday, april 23, 2009.

Device

  • Modelo / Serial
  • Descripción del producto
    Press release: Voluntary Recall of blood glucose meters with incorrect readings (i-sens Model CareSens II)
  • Manufacturer

Manufacturer