Events

Rappel de Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent used for the isolation of HLA Class II+ cells from human peripheral blood)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Technologies 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-2014-RN-00416-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-08
  • 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-00416-1
  • 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
    The manufacturer of dynabeads hla class ii, life technologies as, advises that the listed lots have decreased antibody performance and may not isolate sufficient levels of hla class ii cells required for further testing. lot 142281200 is still within specification, however testing has indicated that it might lose reactivity prior to its expiry date.
  • Action
    Life Technologies is requesting their customers to inspect their stock and dispose of all units from the affected lots. Lot 142281200 can continue to be used until replacement stock is available.

Device

Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent ...
  • Modèle / numéro de série
    Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)(reagent used for the isolation of HLA Class II+ cells from human peripheral blood)Catalogue Number: 21004DLot Numbers: 135384110 (Expiry Date: 09/2014)142281200 (Expiry Date: 02/2015)ARTG Number: 212748
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd