Events

Retiro De Equipo (Recall) de VITROS 5,1 FS System

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-00607-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-07
  • 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-00607-1
  • 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
    Ortho clinical has received two complaints:1) when a customer installed the add that supported the new vitros chemistry products hba1c reagent kit, the vitros 5,1 fs system posted the two condition codes ua7-239 and syd-024. the condition codes occurred because the short assay name for the new vitros assay had the same name as a user defined assay currently in use on their vitros 5,1 fs system. as a result, the user defined assay target was deleted from their system.2) when a customer installed the add, their system became unresponsive (screen freeze occurred) that required the vitros 5,1 fs system to be restarted; the system posted condition code uz0-047 after the restart was initiated.Due to a software coding error, for both scenarios, all default settings were restored from the add instead of retaining the user modified (configured) parameters and the operator was not alerted by the system.
  • Acción
    OCD has determined that the root cause of this anomaly is due to an error in the software code. The resolution is currently under development and will be available in a future version of software. In the interim, OCD has provided workaround instructions to assist end users mitigate this issue. This action has been closed-out on 15/08/2016.

Device

VITROS 5,1 FS System
  • Modelo / Serial
    VITROS 5,1 FS SystemProduct Codes: 6801375 and 6801890Unique Device Identifier Number: 10758750001132 and 10758750001644ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics