Events

Rappel de Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. 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 Bio-Strategy 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-2017-RN-00645-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-22
  • 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-2017-RN-00645-1
  • 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 has recently identified an impurity (bacterial endotoxins) in the raw material used for the final formulation of the finished product of dynabeads hla class ii and dynabeads hla cell prep ii. their investigation determined that the presence of these endotoxins along with any deviation from the recommended cell isolation temperature in the user manual (e.G. performing some steps or storing product at room temperature) may reduce cell viability and lead to failure of the negative control.
  • Action
    Bio-Strategy are advising users to discontinue use of the affected material immediately, and to quarantine and place all unused product in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection, and will provide replacement product or issue credit..

Device

Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD)Dynabeads HLA Class IICatalogue Number: 21003Lot Numbers: 00461955, 00477414, 00480193Catalogue Number: 21004DLot Numbers: 00461951, 00469604, 00477401, 00480209 Dynabeads HLA Cell Prep IICatalogue Number: 21903Lot Number: 00469606, 00477408, 00480204Catalogue Number: 21904Lot Numbers: 00455989, 00461965, 00469615, 00492942
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd