Events

Rappel de iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia Pty 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
    RC-2015-RN-00671-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00671-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    The ichemvelocity systems do not maintain the on-board strip stability claim of 10 days at 18-28 degrees celsius at 20-80% relative humidity (rh) as stated in the ichemvelocity product labelling. the on-board strip stability is affected by temperature and humidity in your laboratory. test results may be affected as indicated below:false low or false negative results: ketone, bloodfalse high or false positive results: bilirubin, urobilinogen, glucose, nitritefalse high results: leukocytesascorbic acid, protein and ph are not affected.
  • Action
    Beckman Coulter is providing an updated stability guide and additional handling instructions to ensure the stability of the test strips. The manufacturer, Iris International, has determined that the Strip Provider Module is not maintaining the humidity levels associated with the original on-board strip stability claim and is urgently developing a corrective action. This action has been closed-out on 06/09/2016.

Device

iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips
  • Modèle / numéro de série
    iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry StripsStrip part numbers 800-7204 and 800-7204-001
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd