Events

Retiro De Equipo (Recall) de AQUIOS CL Flow Cytometry System. An in vitro medical device.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Beckman Coulter Australia Pty Ltd.

¿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-2018-RN-00098-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-02-19
  • 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-2018-RN-00098-1
  • 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
    Aquios cl system will associate the wrong sample id with results in the event the following sequence occurs: -the stat button is selected within aquios cl software and the user opens the single-tube loader door. - user creates a test request when prompted, places a specimen tube in single tube loader, and closes the single-tube loader door. - the stat button is selected again and the user opens the single-tube loader door within 15 seconds or less of loading the first sample and before the “details” column on running screen changes to “prepping” for that sample. - user removes the first specimen tube and replaces with a different specimen tube. this issue was discovered internally during a verification test. there have been no reported similar events from the field.
  • Acción
    Beckman Coulter has released the software correction for this issue at the end of January 2018. A Beckman Coulter Field Service Engineer will contact users to schedule the installation of the software upgrade. In the interim, users are advised to follow the steps and warnings outlines in the IFU when running STAT specimens to avoid sample mis-identification. When running multiple specimen via the single tube loader, wait for the currently loaded specimen to be in the "incubating" status in the "details" column on the Running screen before selecting the STAT button or attempting to cancel the run.

Device

AQUIOS CL Flow Cytometry System. An in vitro medical device.

Manufacturer

Beckman Coulter Australia Pty Ltd