Events

Rappel de Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devices

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Roche Diagnostics Australia Pty Limited.

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-2018-RN-00002-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-12
  • 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-2018-RN-00002-1
  • 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
    Roche diagnostics have been made aware of issues regarding leaking and sticking reagent dispensers that may lead to the incomplete dispensing of a reagent required for the staining reaction. this in turn could result in light or absent staining, which without any mitigations, could cause a delay or an error in diagnosis.
  • Action
    The manufacturer is producing new lots and customers will be notified when corrected product is available. In the interim, affected kits may continue to be used by customers but the affected kits must only be used in conjunction with same-slide controls. These controls must be appropriate for each assay and capable of detecting false negative results. For assays that directly relate to clinical therapy decision making, it is additionally important to select a same slide positive control tissue with sufficient sensitivity to detect small decreases in intensity that may cause borderline positive cases to appear as negative.

Device

Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devices
  • Modèle / numéro de série
    Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devicesOptiView DAB IHC Detection Kit Marial Number 06396500001Lot Number Y11625, Y15571, Y19271ultraView DAB IHC Detection KitMaterial Number 05269806001Lot Number Y09284, Y15384OptiView Amplification Kit Material Number 06396518001Lot Numbers: Y15435, Y19322Hematoxylin IIMaterial Number 05277965001Lot Numbers: Y10759, Y13938, Y17402, Y17403, Y21312, Y22561ARTG 174896 and 174922
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited