Alerta De Seguridad para TRUEtrack and TRUEtest Blood Glucose Test Strips

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

¿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
    2016-07-20
  • Fecha de publicación del evento
    2016-07-20
  • 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
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: truetrack and truetest blood glucose test strips the health canada has posted a medical device safety alert concerning the truetrack and truetest blood glucose test strips, manufactured by trividia health, inc. the model and lot numbers affected by this issue are described below: truetrack blood glucose test strips [model number: a3i20-80, a3i20-81; lot number: rs4567ica, rs4704ica] truetest blood glucose test strips [model number: e3i20-80, e3i20-81; lot number: ps2284ica, ps2316ica, ps2335ica] a limited number of sealed test strip vial boxes from certain blood glucose test strip lots may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can affect strip performance. in particular, test strips exposed to the environment may provide incorrect low blood glucose results. according to the manufacturer, inaccurate low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment. for details, please refer to the health canada’s websites: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59384r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 july 2016.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: TRUEtrack and TRUEtest Blood Glucose Test Strips
  • Manufacturer

Manufacturer