Events

Rappel de VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and VITROS 5600 Integrated Systems)

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-2017-RN-00941-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-30
  • 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-2017-RN-00941-1
  • 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 clinical diagnostics (ortho) has determined that negatively biased results may occur when processing citrate plasma samples using vitros chemistry products phyt slides. as a result, citrate plasma is being removed as a recommended specimen type for vitros phyt slides. internal testing by ortho confirmed negatively biased patient results using vitros phty slides for citrate plasma samples. the majority of the bias may be attributed to the dilution effect of the liquid anticoagulant in the citrate plasma tubes with the sample. serum and/or heparin plasma samples obtained from the same patients did not exhibit biased results. the average negative bias observed using citrate plasma samples when compared to serum samples is approximately 18% across the phyt reportable measuring range of 3.00–40.00 µg/ml (11.88–158.40 µmol/l).
  • Action
    Citrate plasma is being removed as a recommended specimen type for VITROS PHYT Slides. 1. Immediately discontinue using citrate plasma samples for VITROS PHYT Slides: 2. Retain this notification as verification of the revised instructions. 3. Notify laboratory and medical staff of this change. 4. Continue using heparin plasma or serum samples to process VITROS PHYT Slides. 5. Complete the supplied Customer Acknowledgement form of Receipt and return. 6. Post the notification by each VITROS System or with the user documentation. 7. Forward the notification if you have distributed these products outside of your facility.

Device

VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with ...
  • Modèle / numéro de série
    VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and VITROS 5600 Integrated Systems)Unique Identifier Number: 10758750004690Product Code: 8298671Affects expired, current (in date) and future products GENsARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd