Events

Retiro De Equipo (Recall) de UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611). 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-01619-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-13
  • 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-01619-1
  • 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 certain lots of dxc wash concentrate ii can cause a failure in calibration of thermo-fisher lithium reagent (ref a19611). the consequence of calibration failure does not allow for patient results to be generated. lithium calibration failure can potentially lead to a delay of reporting lithium results. patient results reported under acceptable calibration and quality control evaluation are not affected by this issue.
  • Acción
    Beckman Coulter is advising Thermo-Fisher Lithium assay users to discontinue use of affected DxC Wash Concentrate II lots and discard any unused reagent bottles. Replacement product will be provided. Reassessment of past results is not required.

Device

UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611)...
  • Modelo / Serial
    UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611). An in vitro diagnostic medical device (IVD).Wash Concentrate IIReference Number: 445865Lot Numbers: Z505212 (expiry 30 April 2017), Z507201 (expiry 30 June 2016), Z511202 (expiry 31 October 2017)ARTG Number: 245295
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd