Events

Retiro De Equipo (Recall) de AQUIOS CL Flow Cytometry System. 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 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-2017-RN-01101-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-23
  • 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-2017-RN-01101-1
  • 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
    As a result of internal investigations, beckman coulter has learned that an erroneous configuration setting during servicing may be possible on the aquios cl instruments. if the incorrect configuration occurs, the probe may aspirate samples only from a single tube and will not aspirate samples from the remaining tubes in the cassette. the probe would repeatedly aspirate from a single tube position in the cassette, resulting in erroneous patient results for the remaining tubes in the cassette. this causes a mismatch between the test result given and the sample id.
  • Acción
    1. Quality Control samples must be run utilising the control cassette and the autoloader. The controls will not pass if this issue exists on the unit, when run using the autoloader. If the controls do not pass, immediately contact a Beckman Coulter representative. 2. BEC Service organisation will be in contact to ensure that the configuration settings are correct.

Device

AQUIOS CL Flow Cytometry System. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    AQUIOS CL Flow Cytometry System. An in vitro diagnostic medical device (IVD)Part Number: B30166ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd