Events

Alerta De Seguridad para Accu-Chek Performa Nano

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

¿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
    2016-07-19
  • Fecha de publicación del evento
    2016-07-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160719.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: roche accu-chek performa nano the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning accu-chek performa nano manufactured by roche diabetes care. the affected lot numbers are 10135127 and 10134053. during internal testing, the manufacturer has detected the code key to be missing in 1,200 accu-chek performa nano kits out of the affected lots. the accu-chek performa nano blood glucose meter cannot be operated without the pre-inserted code key. according to the manufacturer, appropriate corrective measures to the production process have been implemented. new accu-chek performa nano kits will be available shortly. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-11-july-15-july-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 july 2016.

Device

Accu-Chek Performa Nano
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Accu-Chek Performa Nano
  • Manufacturer
    Roche Diabetes Care

Manufacturer

Roche Diabetes Care