Events

Rappel de VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5,1 FS/4600 and 5600 Systems). 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-2016-RN-01627-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-14
  • 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-01627-1
  • 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 identified the potential for biased urine protein results using vitros upro slides. the following observations were made when using vitros upro slides:-1. variability gen to gen for patient samples. impact to results: magnitude of bias is dependent upon the gen;-2. variability in results for random and 24-hour urine samples with low specific gravity. impact to results: unexpected increase in the number of results exceeding the reference intervals for random and 24-hour urine samples.; and-3. negatively biased results. impact to results: negatively biased results versus the ortho pyrogallol red comparative method.Ortho is providing users with the results of their internal testing that details the levels of bias observed for each of the scenarios above.Gens 12-18 are affected, however the gen 12 and 13 product have expired.
  • Action
    Ortho is advising users to immediately discontinue using and discard all VITROS UPRO Slides remaining in their inventory. Ortho will credit accounts for any discarded VITROS UPRO Slides and VITROS Chemistry Products Calibrator Kit 10 and/or VITROS Chemistry Products UPRO Performance Verifier I & II. Any concerns users may have regarding previously reported urine protein results should be discussed with the Laboratory Medical Director to determine the appropriate course of action. As Ortho is unable to provide replacement VITROS UPRO Slides at present, they recommend laboratories use an alternative method until further notice by Ortho of future product availability.

Device

VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5...
  • Modèle / numéro de série
    VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5,1 FS/4600 and 5600 Systems). An in vitro diagnostic medical device (IVD).VITROS UPRO Slides GENs 14, 15, 16, 17 & 18Product Code: 6800120Expiry Date range: 1 Jan 2017 to 1 May 2018ARTG Number: 232251
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd