Events

Retiro De Equipo (Recall) de AU680 chemistry analysers with software version 4.05. 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-2016-RN-01426-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-03
  • 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-2016-RN-01426-1
  • 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 identified two issues occurring on au680 analysers installed with software version 4.05 that may cause a delay in reporting test results.Issue 1: only occurs with non-beckman coulter reagents. the “(” flag, which indicates a shortage of cleaning solution for contamination parameters, is unintentionally attached to test results depending on specific programming in the contamination parameters screen. there is no impact to test results, however the unintentional “(” flag may cause confusion regarding the volume of cleaning solution and unnecessary concern regarding potential carry-over.Issue 2: sample blank tests (total bilirubin and direct bilirubin) included in a qc profile are not analysed when requisitioned from the stat status > qc screen and run on the stat table. no qc results are initially generated for sample blank tests (total bilirubin and direct bilirubin). however, re-running the tests individually will generate the appropriate test results.
  • Acción
    Beckman Coulter is providing temporary workarounds in the customer letter, in the form of step-by-step instructions to prevent each software issue. Beckman Coulter will resolve these issues in the next release of the AU680 software.

Device

AU680 chemistry analysers with software version 4.05. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    AU680 chemistry analysers with software version 4.05. An in vitro diagnostic medical device (IVD).ARTG Number: 236636
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd