Events

Alerta De Seguridad para UREA/BUN for Modular system

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

¿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
    2015-04-09
  • Fecha de publicación del evento
    2015-04-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150408.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 urea/bun for modular system medical device manufacturer, roche, has issued a medical device safety alert concerning its urea/ blood urea nitrogen (urea/bun) for modular system. the affected reference numbers are 11729691216, 11929470216, 11929488216, 11929496216, 11929500216 and 11489364216. according to the manufacturer, rounding error occurred during calculation of measuring ranges and technical limits in different units. the error leads wrong measuring ranges and technical limits being stated in the instruction of use and setting in the analyzers. thus, these values have to be corrected as well as harmonized in case where the values stated in the parking insert and setting is not coherent the manufacturer has corrected the measuring range and technical limit for urea/urea nitrogen assay and harmonized in the packing insert as well as in the settings for serum and urine for modular analytics p and d. 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 9 april 2015.

Device

UREA/BUN for Modular system
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche UREA/BUN for Modular system
  • Manufacturer
    Roche

Manufacturer

Roche