Events

Rappel de ADVIA Centaur CP – BNPCatalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)

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-00878-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-08
  • 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-00878-1
  • 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 received complaints of failed calibrations on the advia centaur® cp system when using bnp kit lots ending in 172. siemens has confirmed that the failed calibration is due to an error on the advia centaur cp master curve card. the master curve card error results in a low calibration deviation outside the specified calibration evaluation range when using kit lots ending in 172 on the advia centaur cp. an invalid calibration status will prevent bnp results from being generated and may delay the time to result for bnp. if the calibration is successful, the results will be valid and there is no risk to health.
  • Action
    Siemens is advising that if a successful calibration is achieved with BNP kit lots ending in 172 and quality control results are in range, you can continue to report patient results. If unable to obtain a successful calibration on the ADVIA Centaur CP with BNP kit lots ending in 172, please switch to an alternate lot of BNP. This action has been closed-out on 31/08/2016.

Device

ADVIA Centaur CP – BNPCatalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)
  • Modèle / numéro de série
    ADVIA Centaur CP – BNPCatalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)Siemens Material Numbers (SMN): 10309044 and 10309045 Lot Numbers: lots ending in 172 (Expiration date: 17 April 2015)ARTG Number: 175075
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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