Events

Rappel de Randox Liquid Assayed Specific Protein Controls. 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 Randox Australia 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-2018-RN-00508-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-31
  • 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-2018-RN-00508-1
  • 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
    Randox have confirmed that free kappa light chains in certain liquid assayed specific protein controls increase over the shelf life of the product. the quality control results which are not within range can lead to a delay in reporting free kappa light chains results.Free kappa light chains are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for multiple myeloma through review of the ratio with free lamda chains. a short delay in reporting this result is unlikely to prevent diagnosis of these progressive diseases and therefore is unlikely to pose an immediate risk to health.
  • Action
    Randox is advising users to be aware of the issue and place the Customer Letter with any remaining kits. A revised IFU is also being supplied to users which outlines this issue to users under "Storage and Stability".

Device

Randox Liquid Assayed Specific Protein Controls. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Randox Liquid Assayed Specific Protein Controls. An in vitro diagnostic medical device (IVD). Catalogue Number: PS2682GTIN: 05055273204896Catalogue Number: PS2683GTIN: 05055273204902Catalogue Number: PS2684GTIN: 05055273204919ARTG Number: 199684
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA