Events

Rappel de EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics use. Intended for use in immunohistochemistry)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Dako 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-2015-RN-00964-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-12
  • 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-2015-RN-00964-1
  • 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
    Dako has determined that there is a defect in one lot of a buffer used in the manufacturing of some corresponding lots of the envision flex/hrp visualisation reagent. specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualisation reagent was used with four antibodies against the biomarkers epstein-barr virus (ebv), mum-1, wilms’ tumor1(wt1) protein and smooth muscle actin (sma). negative control antibodies in the same run were negative, and did not show the non-specific staining.
  • Action
    Dako is advising users to destroy any remaining lots of affected units. Dako is recommending that users re-evaluate test results from affected lots. This action has been closed-out on 25/08/2016.

Device

EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics...
  • Modèle / numéro de série
    EnVision Flex/HRP visualisation reagent, part of EnVision Flex/Flex+ Kits(For invitro diagnostics use. Intended for use in immunohistochemistry)Multiple products affectedProduct Codes: K8000, K8002, K8023, K8010, K8012, K8024 and GV800Multiple Lot Numbers affectedARTG Number: 199416
  • Manufacturer
    Dako Australia Pty Ltd

Manufacturer

Dako Australia Pty Ltd