Events

Rappel de VITROS Performance Verifier I for unconjugated bilirubin (Bu)

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.

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-00465-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-05
  • 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-00465-1
  • 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
    Investigations have been performed by ortho clinical diagnostics to investigate and address an increase in customer complaints generated for low outside the range of means pv level i results on multiple vitros bu reagent lots and multiple vitros pv lots. review of the customer complaints indicate that some customers are observing results that are outside the range of means (rom), within 0.1 mg/dl of the low end.The differences observed in bu range of means capabilities are not clinically significant and the accuracy of the patient sample results is not impacted by this situation, however there is potential for results to be delayed.
  • Action
    New Assay Sheets containing the revised Range of Means for Bu have been made available on the VITRIOS website. This action has been closed-out on 02/05/2017.

Device

VITROS Performance Verifier I for unconjugated bilirubin (Bu)
  • Modèle / numéro de série
    VITROS Performance Verifier I for unconjugated bilirubin (Bu)Product Code: 8067324 AUST L 25922Lot numbers: A3823, C4084, Q2961, T3161, V3297, X3569 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics