Events

Rappel de Access BR Monitor. 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 Beckman Coulter 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-00500-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-21
  • 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-00500-1
  • 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
    Beckman coulter has been informed that a study completed by the french competent authority ansm showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu). the ansm’s preliminary study demonstrated that 10 out of 27 patients diagnosed with cancer in non-remission had a result below the access br monitor url. in this preliminary study, at the cutoff of 31.3 u/ml designated in the access br monitor ifu, the assay achieved a sensitivity of 63% and a specificity of 100% for patients in non-remission.As a result, beckman coulter is evaluating the access br monitor cutoff. the conclusions of this evaluation are planned to be available by the third quarter of 2017.
  • Action
    Beckman Coulter is advising users that they are currently evaluating the Access BR Monitor cutoff. Users are reminded of the limitations of the assay which are included the current IFU and detailed in the customer letter. These relate to the intended use of the assay as an aid in the management of breast cancer patients and not as a screening tool, the interpretation of CA 15-3 antigen concentration results and the laboratory's establishment of reference ranges to assure proper representation of specific populations.

Device

Access BR Monitor. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Access BR Monitor. An in vitro diagnostic medical device (IVD)Reference Number: 387620All non-expired lots and future lotsARTG Number: 213975
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd