Events

Retiro De Equipo (Recall) de ORTHO PROVUE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL DIAGNOSTICS.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    93022
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Ortho clinical diagnostics (ortho) has initiated this recall to customers with an ortho provue analyzer on which the reader camera brightness value (brillo) was detected to be outside of the specified range. the approved specification for the ortho provue? reader camera brightness is 101 to 128. exceeding the upper range limit of 128 could potentially affect the classification of very low strength (<1+) reactions and may grade the reactions negative instead of as indeterminate ("?"). however the risk is reduced by the fact that any processed cards are read at the same camera brightness (brillo) setting that was established at the time that the reference image was created after optics alignment and adjustment procedures were performed.

Device

ORTHO PROVUE
  • Modelo / Serial
    Model Catalog: MTS213784 (Lot serial: 057-171-1749)
  • Descripción del producto
    ORTHO ProVue Analyzer
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS