Events

Retiro De Equipo (Recall) de Access 2 Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD) Access 2, Access 2, Re-manufactured and the UniCel DxC 600i SYNCHRON Access Clinical Systems

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-00369-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-17
  • 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-00369-1
  • 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
    It has been determined that a circuit board that controls motor functions in specific instrument systems can affect device positioning on the pipettor and incubator belt while the instrument is running. users may experience the following errors that may cause a delay in the reporting of patient results: - an incubator belt motion error which can result in the instrument going into the not ready mode and cancellation of all in-process tests; and/or - z pipettor motion errors which can result in cancelled tests.In the worst case scenario, the potential harm would be a delay in patient diagnosis and/or treatment, with a potential worst case severity of permanent injury. the probability of harm for this event is unlikely.
  • Acción
    Beckman Coulter (BC) is advising users to adhere to the following interim instructions. If you experience: - z pipettor motion errors, to re-run any cancelled tests; and/or - incubator belt motion errors. please review the associated event on the ‘Event Log’ screen and follow the troubleshooting instructions provided. Users are further advised that they will be contacted by their BC service representative to schedule a visit to replace the circuit board on their instruments as a permanent fix.

Device

Access 2 Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD) Access 2, Acc...
  • Modelo / Serial
    Access 2 Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD)Access 2, Access 2, Re-manufactured and the UniCel DxC 600i SYNCHRON Access Clinical SystemsReference Numbers: 81600N, 386220, A25637, A25638 Multiple Instrument Serial NumbersARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd