Events

Rappel de Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCell ABO/I-II ID-DiaCell ABO/I-II-III ID-DiaCell I-IIID-DiaPanelID-DiaCell I-II-IIIID-DiaCell I-II-III AsiaID-DiaScreen ProphylaxID-DiaPanel Plus 6ID-DiaCell ABOID-DiaCell lP-llP-lllPID-DiaPanel-P

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-Rad Laboratories 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-00241-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-28
  • 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-00241-1
  • 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
    Bio-rad has identified an issue in relation to unexpected reactions primarily on eluates and qc samples but also with some patient samples when using id-diacell products. there is the potential for false positive results.
  • Action
    Bio Rad Laboratories is advising users to re-test with a new kit if they are doubtful of the results and if doubts remain after re-testing, to use an alternative testing method. Users are further advised to disseminate this information to relevant personnel within their facilities.

Device

Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCel...
  • Modèle / numéro de série
    Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCell ABO/I-II ID-DiaCell ABO/I-II-III ID-DiaCell I-IIID-DiaPanelID-DiaCell I-II-IIIID-DiaCell I-II-III AsiaID-DiaScreen ProphylaxID-DiaPanel Plus 6ID-DiaCell ABOID-DiaCell lP-llP-lllPID-DiaPanel-P Multiple Catalogue NumbersAll unexpired lotsARTG Number: 213161
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd