Events

Alerta De Seguridad para IH-1000

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

¿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
    2013-06-17
  • Fecha de publicación del evento
    2013-06-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130617.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: bio-rad ih-1000 the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning ih-1000, manufactured by bio-rad. the affected product reference number is 001000 and all software versions are affected. in some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed. in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore, this issue might lead to a wrong result released to the host if the 3 following conditions are met: a result is returned as negative while the reaction is positive, double population, or requires a human interpretation and, this negative result is consistent with the global interpretation of the test and, the system is configured without the second reading function activated for all tests results. the manufacturer is providing work around instructions as an interim measure. a software update will be implemented to permanently correct the issue. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00593-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 june 2013.

Device

IH-1000
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bio-Rad IH-1000
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad