Alerta De Seguridad para MiniCollect Complete 1ml 9NC Coagulation Sodium Citrate 3.2%

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

¿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
    2017-12-18
  • Fecha de publicación del evento
    2017-12-18
  • 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: greiner bio-one minicollect complete 1ml 9nc coagulation sodium citrate 3.2% medical device manufacturer, greiner bio-one, has issued a medical device safety alert concerning its minicollect complete 1ml 9nc coagulation sodium citrate 3.2% [item number: 450556; lot number: a17083kp; expiry date: 19 february 2019]. the manufacturer became aware that the affected product partly showed not enough additive which might cause falsification of analysis results, if the collected blood sample was used for analysis. the affected users are instructed to send back all products of the affected item or verifiably scrap the products and confirm the scrapping to the manufacturer. according to the manufacturer, 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 18 december 2017.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Greiner Bio-One MiniCollect Complete 1ml 9NC Coagulation Sodium Citrate 3.2%
  • Manufacturer

Manufacturer