Events

Rappel de iChem Velocity Urine Chemistry Strips. An in vitro diagnostic medical device (IVD)

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-00806-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-04
  • 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-00806-1
  • 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 manufacturer, iris international has determined that sample probe misalignment or bending on the ichemvelocity may lead to a remote possibility of false negative results due to inadequate strip dosing. the manufacturer'sinvestigation was initiated based on customer complaints for control failures. iris international has become aware of a manufacturing defect where a glucose pad was placed in the location intended for the protein pad on a subset of vials numbered 14996 through 15859 (with the exception of vials 15315 and 15316 within that series) within lot number 7204081a.The manufacturing defect will cause:· consistent false negative results in the presence of proteinuria.· false positive urine protein results may occur when patient specimen contains glucose.· quality control failures for protein results.
  • Action
    Beckman Coulter is advising users to inspect and discard any remaining inventory of affected vials. Beckman Coulter recommends consulting with the Laboratory Director to determine if a review of previously reported results is required. This action has been closed-out on 18/08/2016.

Device

iChem Velocity Urine Chemistry Strips. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    iChem Velocity Urine Chemistry Strips. An in vitro diagnostic medical device (IVD)Lot Number: 7204081AExpiry Date: 02/2016Vials numbered 14996 through 15859 (except 15315 and 15316)ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd