Events

Retiro De Equipo (Recall) de EliA IgG Conjugate. 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 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-00599-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-05-27
  • 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-00599-1
  • 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
    Investigation of complaints received has concluded that when using elia ccp well (14-5515-01) in combination with elia igg conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01), anti-ccp-signals can be elevated for the listed conjugate lots.The positive bias of the elia ccp test will change a small percentage of test results from negative to equivocal and equivocal or high negative to low positive.Testing on clinical samples of both confirmed rheumatoid arthritis (ra) patient sera, healthy blood donors and other disease controls resulted in < 1% of the samples changing from negative to positive, according to current cut-off ranges (total study includes 472 samples). the results of the assay evaluation studies performed confirm the variance to be within current clinical performance, and it is concluded that the clinical impact of the observed bias is negligible.
  • Acción
    The sponsor is advising customers to stop using EliA CCP Well (14-5515-01) in combination with EliA IgG Conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01) of the affected lots as stated. The sponsor will provide unaffected EliA IgG conjugate lots as soon as they become available. This action has been closed-out on 15/02/2017.

Device

EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).EliA IgG Conjugate 50Article Number: 83-1017-01EliA IgG Conjugate 200Article Number: 83-1018-01EliA IgG ConjugateArticle Number: 83-1005-01 EliA IgG ConjugateArticle Number: 83-1002-01Multiple Lots and Kits affectedARTG Number: 229585
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd