Events

Notificaciones De Seguridad De Campo acerca de VITROS® Systems using Software Version 3.2.2 and Below

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.

¿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
    Slovenia
  • Fuente del evento
    AMPMDRS
  • 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
    As part of a field safety corrective action, ortho clinical diagnostics (ortho) initiated this urgent field safety notice due to a vitros system software timing anomaly that could cause two different sample metering scenarios that may lead to erroneous results. scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample. scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) causing sample b to be contaminated and diluted by sample a. .

Device

VITROS® Systems using Software Version 3.2.2 and Below

Manufacturer

Ortho Clinical Diagnostics