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-01325-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-16
  • 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-01325-1
  • 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
    Beckman coulter has determined that when aquios cl systems are connected to a laboratory information system (lis), the system may duplicate sample requests leading to sample mis- identification. for this to occur, the following conditions must be met:- the aquios cl flow cytometer is connected to an lis; and- the aquios cl system has the default test enabled; and- host query is enabled in lis setup screen on system; and- there are multiple cassettes in the autoloader; and- the lis host query response is received in a brief time window before lis response timeout occurs.When all of these conditions are met, a sample will follow two paths of test request creation (lis and default test). all software versions (2.0, 2.0.1 and 2.1) in existence are impacted by this issue and all applications used on the aquios cl are impacted by this issue.
  • Acción
    Beckman Coulter is advising users to immediately perform an adjustment to the software options on the system by turning off the DEFAULT TEST. This will eliminate the issue and result in one sample producing one set of results. After doing this, samples with no LIS test requests will become entries in the incomplete tab. Beckman Coulter will be contacting laboratories to assist in determining if any samples previously run are impacted.

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: B30166All software versions (2.0, 2.0.1 and 2.1)All applications used on the AQUIOS CL SystemARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd