Events

Rappel de Iris iChem Velocity Automated Urine Chemistry System

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 Iris International.

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
    18899
  • Date de mise en oeuvre de l'événement
    2015-07-28
  • 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
    Iris has confirmed the ichem velocity automated urine chemistry systems do not maintain the on-board strip stability claim of 10 days at 18-28 degrees c at 20-80% relative humidity as stated in the product labeling. the on-board strip stability is affected by temperature and humidity in the laboratory. if a laboratory operates outside of the defined parameters , test results may be affected as indicated below:, * false low or false negative results: ketone, blood, * false high or false positive results: bilirubin, urobilinogen, glucose, nitrite, * false high results: leukocytes, ascorbic acid, protein and ph are not affected.
  • Action
    Instructions for use to be updated

Device

Iris iChem Velocity Automated Urine Chemistry System
  • Modèle / numéro de série
    Model: 800-3042, 800-3043, 800-3044, 800-3075, 800-3076, 800-3564, 800-7100, 800-7101, 800-7102, 800-7103, 800-7106, 800-7157, 800-7162, 800-7163, 800-7166, Affected: Manufactured between Apr-2011 and Jun-2015
  • Manufacturer
    Iris International

Manufacturer

Iris International