Events

Rappel de VIDAS Anti HBs Total II. 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 Biomerieux 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-2014-RN-01002-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-09-16
  • 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-2014-RN-01002-1
  • 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
    The information referenced in the current ifu is incorrect with regards to specimen stability for samples in stoppered tubes. in the instruction for use (ifu), the paragraph “specimen stability” states, “the stability of the sample separated from the clot has been validated using samples in stoppered tubes: at 18-25°c for 3 days”. further review identified that the data of the stability study mentioned in the product review development report file (ref. vr11) is “for stoppered tubes, at 18-25°c for 8 hours”. the instructions for use should state: “the stability of the sample separated from the clot has been validated using samples in stoppered tubes at 18-25°c for 8 hours”.
  • Action
    BioMerieux is notifying their customers that the IFU incorrectly states that sample is stable for 3 days at 18-25 degrees C once separated from the clot. The correct stability is 18-25 degrees C for 8 hours. This action has been closed-out on 01/03/2016.

Device

VIDAS Anti HBs Total II. An in vitro Diagnostic Medical Device (IVD)
  • Modèle / numéro de série
    VIDAS Anti HBs Total II. An in vitro Diagnostic Medical Device (IVD)Reference Number: 30318Lot Number: 1002903980
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd