Events

Rappel de XN-L series 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 Sysmex Corporation.

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
    21663
  • Date de mise en oeuvre de l'événement
    2017-07-05
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Cause
    It has been reported that the wbc could become falsely low when the following steps are performed:, manual mode is selected, whole blood mode (wb), predilute mode (pd) or body fluid mode (bf) is changed to low wbc mode (lw)., the measurement information is input in the manual order dialogue and the menu is closed by selecting 'ok'., no measurement is performed in lw mode, and the mode is then changed to use another measurement mode (ie either wb, pd, bf)., with the next measurement, the wbc result becomes diluted and gives a result half of the correct wbc value.
  • Action
    Software to be upgraded

Device

XN-L series analyser
  • Modèle / numéro de série
    Model: , Affected: XN-L series instruments: version 00-13 and above
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation