Events

Alerta De Seguridad para LifeScan OneTouch® Verio® IQ Blood Glucose Meters

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

¿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
    2012-03-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120321b.html
  • 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
    Medical Device Safety Alert
  • Causa
    Field safety notice: lifescan onetouch® verio® iq blood glucose meters the health canada reported a type ii medical device recall concerning onetouch® verio® iq blood glucose meters (model no.: 011-838) manufactured by lifescan europe. a software issue has been identified, under very specific circumstances, produces an error that causes the meter to turn itself off when a user attempts to access the "results log" to view stored test results. the meter enters the set-up mode and requires the user to confirm the date and time settings before testing. for more details, please visit the following website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

LifeScan OneTouch® Verio® IQ Blood Glucose Meters
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: LifeScan OneTouch® Verio® IQ Blood Glucose Meters
  • Manufacturer
    LifeScan Europe

Manufacturer

LifeScan Europe