Events

Rappel de Anti-dsDNA Kit. 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 Immuno 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-2014-RN-01362-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-12-24
  • 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-2014-RN-01362-1
  • 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
    Specific product codes for the anti-dsdna kit (used to test for antibodies to dsdna), were omitted in error from the packaging material. customers have received the correct products, however due to the omission of the product code on the outer box it is not clearly identifiable if they have received the 50 tests version (im77 lot c323026) or 100 tests version (im771 lot c323027). the kits can be differentiated by the lot numbers printed on the outer box. please note that the individual component labelling within the kit has not been affected.The tracer and ammonium sulphate solution lot numbers were omitted for these particular lots of product listed above.
  • Action
    A set of labels (stickers) will be provided to customers to place over the existing directions that will correct the problem. The Customer Letter contains detailed instructions on where to place the stickers – including examples in the form of pictures. This action has been closed-out on 02/03/2016.

Device

Anti-dsDNA Kit. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Anti-dsDNA Kit. An in vitro diagnostic medical device (IVD).50 Test kit Batch Number:- C323026 Product Code IM77100 Test kit Batch Number:- C323027 Product Code IM771
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA