Events

Retiro De Equipo (Recall) de enGen Laboratory Automation Systems, 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-00328-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-13
  • 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-00328-1
  • 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 diagnostics (ocd) is advising users of a software anomaly regarding the routing of urine samples which required pre-treatment for assays using vitros chemistry products ca, mg and phos slides. the engen system software currently does not route samples which require acidification pre-treatment to the manual high priority exit location for pre-treatments as intended. in addition, the engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pre-treatment. ocd internal testing has confirmed instances where vitros 5,1 fs, 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen, regardless of the pre-treatment requirements for each selected assay, potentially leading to biased patient results.
  • Acción
    OCD is providing temporary work around instructions for users to prevent the failure mode. A software update will be implemented as a permanent fix. Also, OCD is advising users to discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 11/08/2016.

Device

enGen Laboratory Automation Systems, An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    enGen Laboratory Automation Systems, An in vitro diagnostic medical device (IVD)Affected Versions: Systems configured with enGen Select v5.0 and Custom or Select v3.2.2 and belowProduct Code: ENGEN
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics