Events

Rappel de EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Abacus ALS Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00599-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-05-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00599-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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).
  • Modèle / numéro de série
    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