Events

Rappel de ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) Assay

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Ltd Diagnostics Division.

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-01004-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-17
  • 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-01004-1
  • 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
    Siemens healthcare diagnostics has confirmed increased assay imprecision and a positive bias (increase in index values) in the low end of the assay with the advia centaur systems hbc total (hbct). the increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in false reactive results.The increase in the number of false reactive results may cause additional testing but should not result in the reporting of an increased number of false positive results to physicians. the instructions for use (ifu) recommends that clinical interpretation be made in conjunction with other hbv serological markers.
  • Action
    Siemens is asking customers to discontinue use and discard the affected kit lots. Customers are advised to review the letter with their Medical Director. This action has been closed-out on 18/04/2017.

Device

ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) Assay
  • Modèle / numéro de série
    ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) AssayCatalogue Number: 07566733Siemens Material Number (SMN): 10309508Kit lot numbers: 36217064, 36281064, 36449064, 37406064 and 38177064 Expiration Date: February 10, 2015AUST L number: 93126 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA