Events

Retiro De Equipo (Recall) de Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 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-01259-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-12-23
  • 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-01259-1
  • 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 received an increased number of customer complaints observed after s-cal calibration on the unicel dxh 800 and dxh 600 coulter cellular analysis systems, and the coulter lh 750 and lh 780 hematology systems. customers have reported a variety of issues during calibration including:- an increase in h&h; check messages- low mch recovery in xb- low mchc recovery in xbthese issues are not observed with all analysers and there is no impact to patient results.
  • Acción
    Beckman Coulter is advising users to monitor other quality control performance and adhere to the established maintenance schedule. Beckman Coulter is adjusting the SCAL values for lots starting 4782 and 113160400. This action has been closed-out on 16/05/2017.

Device

Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems.
  • Modelo / Serial
    Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems. Catalogue Numbers: 624519, 179310 and 628026Multiple Kits and Vial Lot Numbers affectedAn in vitro diagnostic device (IVD)ARTG Number: 223050
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd