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-01092-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-09
  • 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-01092-1
  • 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
    Beckman coulter has become aware of a manufacturing defect where multiple strips with multiple missing pads were found inside the strip vial for the affected lot number. if the affected strips are used, it may result in quality control failures and potential false negative results for any or all analytes and erroneous ph results if affected strips are used to assay patient samples.
  • Action
    Beckman Coulter is advising users to discard affected lots. Any affected lots will be replaced by unaffected product. Beckman Coulter is advising users to consult with the Laboratory Director to determine if a retrospective review of results is clinically warranted. 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). Reference Number: 800-7204Lot Number: 7204089B ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd