Events

Rappel de VITROS Immunodiagnostic Products NT-proBNP Assay. 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.

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-00427-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-20
  • 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-00427-1
  • 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
    Internal testing by ortho-clinical diagnostics, inc. (ocd) has determined the need for revisions to the low end of the measuring range for the assay. this revision affects the limit of blank (lob), limit of detection (lod), limit of quantification (loq) and reportable measuring range.
  • Action
    Ortho-Clinical Diagnostics, Inc. (OCD) is providing the updated Instructions For Use (IFU) and instructing the customers to implement the revisions on the VITROS System as below: - For VITROS ECi/ECiQ Systems: Scan the Magnetic Lot Card for Lot 1250 & above. - For VITROS 3600, 5600 Systems: Install ADD DRV 5815 & above. - Update the laboratory procedures and Laboratory Information System, as required. The revision to the low end of the Measuring (Reportable) Range may affect the Laboratory Information System. Users are advised to consult with their Information Technology representative to determine the impact at their facility. IFU documents are also available on the Ortho-Clinical Diagnostics, Inc. (OCD) website.

Device

VITROS Immunodiagnostic Products NT-proBNP Assay. An in-vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VITROS Immunodiagnostic Products NT-proBNP Assay. An in-vitro diagnostic medical device (IVD)VITROS NT-proBNP CalibratorsProduct Code: 6802157GTIN: 10758750002078VITROS NT-proBNP Reagent PackProduct Code: 6802156GTIN: 10758750002061
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics