Events

Rappel de ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - BNP Ready Pack Lot 038174 (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 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-01080-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-08
  • 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-01080-1
  • 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 that there may be an incorrect side label on a small percentage of the advia centaur systems bnp ready packs from reagent lot 038174. incorrectly labelled ready packs are included within kit lots 43305174, 43278174, 43306174 and 43279174. the human-readable side label may incorrectly identify the ready pack as advia centaur systems ft4 ready pack. the ready pack end label and the barcode end label correctly identify the ready pack as the advia centaur systems bnp ready pack and the ready pack will scan correctly as bnp when loaded onto the advia centaur systems. the kit boxes are correctly labelled as bnp. other advia centaur bnp kit lots ending in 174 are not impacted. the reagent in the ready pack has been verified as bnp reagent and will generate valid results when calibrating and running quality control or patient samples using the affected advia centaur systems bnp ready pack kit lots.
  • Action
    Siemens Healthcare Diagnostics(SHD) is instructing their customers to examine their inventory of BNP Ready Packs identified with the human-readable FT4 side labels and discard any affected packs. Siemens representative will provide the product replacement. Siemens is also informing their customers that any results generated with an affected pack are valid; the instruments identify the pack correctly and there is no performance issue with the reagent within the packs. This action has been closed-out on 11/08/2016.

Device

ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - BNP Ready Pack Lot 038174 (An in vitro dia...
  • Modèle / numéro de série
    ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - BNP Ready Pack Lot 038174 (An in vitro diagnostic medical device (IVD))Catalog Number: 02816138 Siemens Material Numbers: 10309044 Kit Lots: 43305174, 43278174Catalog Number: 02816634 Siemens Material Numbers:10309045 Kit Lots:43306174, 43279174Expiration Date: July 11, 2015 ARTG number: 175075
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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