Events

Alerta De Seguridad para HemoCue HbA1c 501 Test Cartridges

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

¿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
    2015-11-25
  • Fecha de publicación del evento
    2015-11-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151125b.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
    Medical device safety alert: infopia hemocue hba1c 501 test cartridges the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning hemocue hba1c 501 test cartridges, manufactured by infopia. the affected products were manufactured in november 2014 with model number 405110 and lot number f14k12k21dl. according to the manufacturer, in some cases the affected product gives elevated results. the manufacturer is advising users not to use the test cartridges from this lot and to discard any remaining stock. for details, please refer to the mhra website: https://mhra.Filecamp.Com/public/file/2bw2-d0857bhd according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 november 2015.

Device

HemoCue HbA1c 501 Test Cartridges
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Infopia HemoCue HbA1c 501 Test Cartridges
  • Manufacturer
    Infopia

Manufacturer

Infopia