Events

Rappel de Siemens ADVIA Centaur Systems HBc Total (HBcT)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Healthcare Diagnostics, Inc.

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
    69292
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0103-2015
  • Date de mise en oeuvre de l'événement
    2014-09-15
  • Date de publication de l'événement
    2014-10-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130184
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • Cause
    Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.
  • Action
    Siemens Healthcare issued An Urgent Medical Device Recall (UMDR) sent to all affected Siemens Healthcare Diagnostics customers in the United States on September 15, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 15, 2014. These notices inform the customer of the imprecision and positive bias and a potential increase in initial reactive results associated with ADVIA Centaur Systems HBc Total Lot 100064. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Each customer will be required to return a completed confirmation fax-back to Siemens.

Device

Siemens ADVIA Centaur Systems HBc Total (HBcT)
  • Modèle / numéro de série
    Lot Number:  36217064, 36281064, 36449064, 37406064, 38177064  Exp.Date:February 10, 2015
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Austria Bahrain Belgium Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iraq Ireland Italy Jordan Latvia Lebanon Lithuania Luxembourg Netherlands Norway Poland Portugal Romania Slovakia Spain Sweden Switzerland Turkey Unit.Arab Emir and Yemen.
  • Description du dispositif
    ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. || Catalog Number: 07566733 || Siemens Material Number: 10309508 || The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA