Events

Retiro De Equipo (Recall) de enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) v8.06

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-2014-RN-00414-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-07
  • 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-2014-RN-00414-1
  • 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
    The engen laboratory automation system is an automated track which integrates clinical analysers and the customer’s lis (laboratory information system). it centrally controls pre-analytical and post-analytical processing as well as sample transport to multiple independent analysers and devices. ortho clinical diagnostics (ocd) internal testing has determined that when a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (storage) prior to the completion of the necessary pending action. a delay in patient test result(s) reporting could occur.
  • Acción
    Laboratories are advised to manually rerun samples that have been prematurely stored. A software modification is currently in development and will be provided once complete. This action has been closed-out on 11/02/2016.

Device

enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) ...
  • Modelo / Serial
    enGen Laboratory Automation Systems configured with Data Innovation, LLC Instrument Manager (IM) v8.06Product Code: 6802883Lot Numbers: enGen Select Versions 3.2.2 and below & enGen Custom versions 3.2.2 and below
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics