Events

Rappel de iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in vitro diagnostic 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-2016-RN-00065-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-03
  • 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-2016-RN-00065-1
  • 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
    There have been complaints indicating that loose or missing analyte pads being found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the ichemvelocity system.If affected strips are used to assay patient samples, the issue has the potential to cause erroneous ph results and false negative results for the following tests:nitrite, glucose, blood, bilirubin, urobilinogen, protein, leukocyte esterase, ketones, and ascorbic acid.There is no impact to the measurement of colour, clarity and specific gravity.
  • Action
    The sponsor is advising users to discard the vial and not use the strips from that vial when loading strips if loose or missing analyte pads are observed. Users should contact the sponsor for product replacement. A review of patients' results is at the discretion of the laboratory director. This action has been closed-out on 16/02/2017.

Device

iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in ...
  • Modèle / numéro de série
    iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in vitro diagnostic device (IVD)Reference Numbers: 800-7212; 800-7212-001; 800-7204; 800-7204-FJRAll Lot and Serial Numbers are affectedARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd