Events

Rappel de iChemVELOCITY Urine Chemistry Analyzers

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
    22701
  • Date de mise en oeuvre de l'événement
    2018-03-08
  • 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 determined that there is a potential for incorrect settings to be installed on north american ichemvelocity urine chemistry analyzers., the installation of international settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations., the installation of colours differ from those stated in the instructions for use (colourless, straw, yellow, amber, red, blue) for output settings will result in incorrect reporting of colours. for example, if green is the colour choice for the output setting instead of blue, green will be reported.
  • Action
    Software to be upgraded

Device

iChemVELOCITY Urine Chemistry Analyzers
  • Modèle / numéro de série
    Model: , Affected: All Instruments with North America System Configuration Settings
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc