Notificaciones De Seguridad De Campo acerca de Reagent Red Blood Cell Products

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Ortho Clinical Diagnostics, Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
  • Fuente del evento
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    If markedly hemolyzed red cell products are used in testing, erroneous (false positive or false negative) results may be generated, which can potentially lead to patient harm. to date, ortho has received no reports of erroneous patient/donor results due to this issue. discuss any concerns you may have regarding previously reported results with your laboratory medical director to determine the appropriate course of action. as a reminder, the precaution section of the instructions for use for these products states: “do not use reagents if marked hemolysis or evidence of contamination is observed.” resolution corrective actions have been implemented and any rrbc product lots that expire after 2016-12-16 should not exhibit this hemolysis. .