Events

Retiro De Equipo (Recall) de VITROS 3600 and 5600 Systems using Software Version 3.2 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
    Recall
  • ID del evento
    RC-2015-RN-01098-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01098-1
  • 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
    Due to a software anomaly, the temperature in the well wash module may be out or range without notification to the operator.Temperature monitoring is performed by the vitros system for each subsystem (i.E. microslide, microtip and microwell). ortho-clinical's investigation confirmed that under very specific conditions, the temperature for the well wash module may be out of range without alerting the operator..If the anomaly occurs, it is possible for the vitros system to process samples outside of the proper temperature range, potentially leading to biased patient result. the results will not have the proper ‘wt’ (wash temperature) result code.
  • Acción
    Ortho-Clinical is providing users with a guide to determine if the unit is affected by the temperature issue. If a temperature is out of range and the status bar indicates that the system is “Ready” or the temperature icon is NOT present, the user is advised to contact the sponsor’s Technical Solutions Centre. Ortho-Clinical is advising users to discuss any concerns regarding previously reported results with the Laboratory Director. This action has been closed-out on 29/08/2016.

Device

VITROS 3600 and 5600 Systems using Software Version 3.2 and Below. An in vitro diagnostic medical...
  • Modelo / Serial
    VITROS 3600 and 5600 Systems using Software Version 3.2 and Below. An in vitro diagnostic medical device (IVD)VITROS 3600 System Product Code: 6802783VITROS 3600 System Software Version 3.2 & BelowProduct Code: 6802866VITROS 5600 SystemProduct Code: 6802413VITROS 5600 System Software Version 3.2 & BelowProduct Code: 6802864ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics