Events

Alerta De Seguridad para AU480 Chemistry Analyzer

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

¿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
    2015-09-29
  • Fecha de publicación del evento
    2015-09-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150929c.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: beckman coulter au480 chemistry analyzer medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its au480 chemistry analyzer [software version 1.81]. a software defect has been identified on newly installed au480 systems with software version 1.81. the defect may generate incorrect test results for 2 step method assays on au480 systems configured with closed channels. new au480 systems configured to allow for full open channels are not affected. the software defect occurs when edit and then confirm are pressed on the specific test parameters screen of closed channels. the result is the measuring point-2 settings will be deleted. the measuring point 2 settings are used for sample blank adjustments for 2 step methods. for samples which may have lih (lipemia, icterus, hemolysis) or other interferant, there is a potential for false high results to be calculated for 2 step method assays on closed channels. 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 29 september 2015.

Device

AU480 Chemistry Analyzer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter AU480 Chemistry Analyzer
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter