Events

Retiro De Equipo (Recall) de QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPC

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abacus ALS 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-00203-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-26
  • 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-00203-1
  • 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
    Investigations into complaints received have shown that in rare cases, the tests mentioned may give either falsely low crp resultsor the measurement flow is interrupted by the error message “faulty reagent addition”. falsely low crp results, in general, may providemisleading information for the diagnosis, therapy and monitoring of inflammatory disorders.The reported issue in a worst case scenario may cause a delay in starting the antibiotic treatment.
  • Acción
    The sponsor is advising users to immediately quarantine and discontinue use of kits from the affected lots. This action has been closed out on 08 Jun 2017.

Device

QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPC
  • Modelo / Serial
    QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPCatalogue Number: 146521Production Lot: HX78Expiry Date: 24/11/2016QuikRead go wrCRP+HbCatalogue Number: 146255Production Lot: HX85Expiry Date: 31/01/2017ARTG Number: 206301
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd