Events

Rappel de DxH 500

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 Beckman Coulter Inc.

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
    21476
  • Date de mise en oeuvre de l'événement
    2017-05-31
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Cause
    The manufacturer has become aware that when the instrument temperature (<18°c to >36.5°c) is exceeded, the dxh 500 allows sample processing and result reporting despite the instructions for use stating that the run sample is inaccessible. results generated in this scenario may be erroneous. additionally:, " the message on the results screen/printout reads instrument temperature instead of instrument temperature out of range., " the results are transmitted to the laboratory information system (lis) without the accompanying instrument temperature out of range message. using the auto-transmit option could lead to the release of erroneous results to the lis.
  • Action
    Software to be upgraded

Device

DxH 500
  • Modèle / numéro de série
    Model: , Affected: Software Versions 1.0.2
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc