Alerta De Seguridad para Ortho BioVue Analyser

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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: ortho-clinical diagnostics ortho biovue analyser the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning its ortho biovue analyser manufactured by ortho-clinical diagnostics. [ product code: 6904579 and software version: 2.12.6 and below ]. the manufacturer has identified an anomaly in ortho vision analyser software that may occur when either: the manufacturer’s field engineer performs a clean-up of the analyser database, or an operator of the vision analyser restores a database backup on the analyser, and dilution trays have not been removed from the instrument prior to restarting the system. in this scenario, the analyser software cannot identify usage history of the wells of the dilution tray on the instrument, and reuse of wells may occur. according to the manufacturer, for tests that involve dilution of patient red blood cells, the reuse of a dilution well can potentially lead to false positive or false negative results. to date, only false positive results have been observed during internal testing. there is a risk of false positive or false negative anti-d testing, which may result in haemolytic transfusion reaction. the manufacturer is reminding users to ensure the dilution wells are removed and disposed of prior to initiating a database restore operation. this issue will be addressed in a future version of the software and a technical bulletin issued to remind users to remove and dispose of dilution wells prior to restoring a database. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00201-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 march 2016.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ortho-Clinical Diagnostics Ortho BioVue Analyser
  • Manufacturer