Events

Retiro De Equipo (Recall) de AQUIOS CL Flow Cytometry System, software versions 2.0, 2.0.1, 2.1. 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-01489-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-06
  • 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-01489-1
  • 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 noted an issue with duplicate sample requests when using the aquios cl systems connected to a laboratory information system (lis).1. host query errora) when aquios cl systems are connected to a laboratory information system (lis) directly or through middleware, the system may duplicate sample requests leading to sample mis-identification. 2. cassette unloading duplicationa) all aquios cl systems may duplicate sample requests if a cassette is not properly unloaded by the instrument. these sample duplications do not result in mis-identification. b) sample id duplication caused by errors with cassette unloading will present as non-sequential duplications. on the review and results screen, one or more sample ids from same instrument (serial number) will be listed with a run time between duplicate sample id entries. both issues described above are present in all software versions (2.0, 2.0.1 and 2.1) and all applications used on aquios cl are impacted.
  • Acción
    Beckman Coulter is working on a software upgrade to permanently correct and eliminate these issues. In the interim, Beckman Coulter is advising users who are experiencing the identified issues to follow the instructions provided on the Customer Letter until the software upgrade has been released and installed. Beckman Coulter will be in contact with users to assist in determining whether previous samples run in laboratories were impacted by host query misidentifications. A retrospective review of results obtained is at the discretion of the Laboratory Manager.

Device

AQUIOS CL Flow Cytometry System, software versions 2.0, 2.0.1, 2.1. An in vitro diagnostic medica...
  • Modelo / Serial
    AQUIOS CL Flow Cytometry System, software versions 2.0, 2.0.1, 2.1. An in vitro diagnostic medical device (IVD) Part Number: B30166 All Software Versions All Applications ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd