Events

Rappel de Leica ASP 300S Analyser

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 Leica Instruments Singapore Pte 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
    18963
  • Date de mise en oeuvre de l'événement
    2015-08-12
  • 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: Leica Microsystems Pty Ltd, New Zealand Branch, 3/33 Spartan Road, Takanini, Auckland 2105
  • Cause
    The manufacturer recently became aware that these devices have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm not to function correctly in the case of an instrument failure., if there is an instrument failure during processing and the remote alarm is relied upon then the missing alarm signal could lead to suboptimal quality tissue processing. in some cases, a re-biopsy of the patient could be necessary in order to obtain another viable tissue sample.
  • Action
    Product to be modified

Device

Leica ASP 300S Analyser

Manufacturer

Leica Instruments Singapore Pte Ltd