Events

Rappel de Dako EnVision FLEX/HPR reagent

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par DakoCytomation.

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
    19174
  • Date de mise en oeuvre de l'événement
    2015-09-22
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Global Science a Bio-Strategy Company (Bio-Strategy Limited), 241 Bush Road, Albany, Auckland 0632
  • 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 visualization reagent. specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualization 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., , 15/01/2016: subsequent to the earlier letter the remaining dako flex ready-to use antibodies were tested using the affected envision flex/hrp visualization reagent . two additional antibodies wereidentified as having a remote potential to affect results. update overview letter sent.
  • Action
    Product to be destroyed

Device

Dako EnVision FLEX/HPR reagent
  • Modèle / numéro de série
    Model: K8000 & K8012, Affected: 20019097 & 20020768
  • Manufacturer
    DakoCytomation

Manufacturer

DakoCytomation