Events

Rappel de VITROS Chemistry Products PHYT Slides. 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 Ortho-Clinical Diagnostics 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-2018-RN-00604-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-23
  • 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-2018-RN-00604-1
  • 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
    Ortho has confirmed customer complaints regarding the potential for imprecise results when using impacted vitros phyt slides. the results obtained were either positively or negatively biased across the vitros phyt slides measuring range of 3.00–40.00 ug/ml (11.88–158.40 umol/l).To date, no adverse events have been reported as a result of this issue.
  • Action
    Ortho is requesting customers to immediately discontinue using and discard all remaining inventory of VITROS PHYT Slides for the affected lots. Ortho will replace remaining inventory of the affected lots or credit accounts.

Device

VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).Unique Identifier Number:10758750004690Product Code: 8298671Generation: GEN 16Coating ID: Coating 0165Multiple Lot NumbersExpiry date:15 March 2018 through to 15 June 2018ARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd