Events

Rappel de ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). 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 Healthcare 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-2016-RN-00180-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-22
  • 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-2016-RN-00180-1
  • 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 has confirmed a lot to lot bias with calibrator e for the advia centaur testosterone assay. siemens’ internal investigation demonstrates:· an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42. · an average negative bias of 7% across the assay range with calibrator e kit lots ending in 43. · the positive bias of lots ending in 42 to the master curve compared to the negative bias of lots ending in 43 to the master curve is the main driver for the negative bias between values generated with lots ending in 42 and 43. the bias of the calibrators to the master curve has been corrected with calibrator e kit lots ending in 44. the risk to health as a result of this issue is negligible. the biases observed across the assay range would not impact clinical management of patients being evaluated for androgen disorders or chemical castration.
  • Action
    Siemens is advising users that Calibrator E with lots ending in 42 and 43 can continued to be used to calibrate Testosterone on the Centaur CP system. Lots ending in 44 and above should be used for other Centaur systems. A review of previously generated results due to this issue is at the discretion of the laboratory.

Device

ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An...
  • Modèle / numéro de série
    ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An in vitro diagnostic medical device (IVD)Catalogue Numbers: 04634452, 04634762, 04636889Siemens Material Number (SMN): 10309079, 10321075, 10335532Multiple Lot numbers affectedARTG Number: 175698
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA