Events

Retiro De Equipo (Recall) de UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System

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-00556-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-05-16
  • 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-00556-1
  • 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
    There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. the events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.In most cases, system flags and/or messages have accompanied the erroneous results, indicating the need to review the results. in rare instances, system flags and/or messages might be absent.
  • Acción
    Users are requested to: 1. Use all available features to assess patient results, including reference ranges, action and critical limits, instrument system flags, codes, messages, delta checks, and decision rules; 2. Follow all Instructions for Use (IFU) pertaining to flow cell error and warning messages, and ensure daily Shutdown is performed; 3. Follow your laboratory’s standard operating procedure for confirming unexpected results; 4. Communicate to your Laboratory Medical Director the need to avoid patient treatment based solely on any single test result, and to interpret all results in the context of other clinical and laboratory features; and 5. Consult with your Medical Director to determine if a retrospective review of results is warranted. In the interim, Beckman Coulter is working on a permanent resolution to detect and flag these unexpected light scatter patterns.

Device

UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System

Manufacturer

Beckman Coulter Australia Pty Ltd