Retiro De Equipo (Recall) de ORTHO VISION Analyzer for ORTHO BioVue Cassettes, software version 2.12.6 and below. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Ortho-clinical diagnostics (ortho) has identified an anomaly in ortho vision analyser software that may occur when either:1. an ocd 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 2. 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.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. no customer complaints or patient injuries have been reported due to this issue.
  • Acción
    Ortho Clinical 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. This action has been closed-out on 20/02/2017.


  • Modelo / Serial
    ORTHO VISION Analyzer for ORTHO BioVue Cassettes, software version 2.12.6 and below. An in vitro diagnostic medical device (IVD)Product Code: 6904579Software Version: 2.12.6 and belowARTG Number: 229946
  • Manufacturer