Events

Retiro De Equipo (Recall) de Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD) Used with systems: Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i 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-2015-RN-01035-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-22
  • 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-2015-RN-01035-1
  • 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 the access cea reagent packs were filled incorrectly. these packs contain insufficient quantity of reagents in one of the pack wells. the impact is dependent upon the instrument and software version installed at the time the reagent lot was in use: access 2 systems, software version 3.3.1 or lower, and access 2i systems, software version 6.1 or lower: - the instrument may have generated incorrect results of 0.0 ng/ml. all other results greater than 0.0 ng/ml are not affected by this issue and are correct. access 2 systems, software version 3.4.2 and access 2i systems, software version 6.2.2 or higher: - the affected packs would be detected by process monitoring, and the pack disabled by the instrument. no patient results generated. unicel dxi systems with all software versions: - the packs wouldbe detected by reagent pack monitoring, and the pack disabled by the instrument. no patient results generated.
  • Acción
    Beckman Coulter is advising users to discard any remaining stocks of the affected lots. Beckman Coulter is recommending users review patients results that were reported as 0.0 ng/mL and did not match the clinical status of the patient, and advise clinicians at the discretion of the Laboratory Director. A software upgrade for Access systems to version 3.4.2 and Access 2i to version 6.2.2 rectifies this issue. This action has been closed-out on 02/05/2017.

Device

Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagn...
  • Modelo / Serial
    Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD)Used with systems: Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems. Part Number: 33200Lot Numbers: 595027 and 595029Expiry Date: 15 Feb 2016 and 28 Feb 2016ARTG Number: 213975
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd