Events

Rappel de Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline 2, Procalcitonin, Folate, DHEA-SO4, CA 19-9, BR Assay for CA 15-3, BR Assay for CA 27.29, BNP (B-type Natriuretic Peptide), In vitro diagnostic medical devices (IVDs)

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-2012-RN-01135-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-08
  • 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-2012-RN-01135-1
  • 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
    The operating range of the advia centaur systems is 18°c to 30°c. the affected assays can product inaccurate results when performed within this operating range. a change in room temperature may increase or decrease assay results, depending on the specific assay and advia centaur system used.This phenomenon is observed when assay results are reported at a temperature different from the temperature at which the assay was calibrated. depending on the frequency of quality control testing and laboratory temperature at the time quality controls are tested, this issue may not always be detected through routine quality control monitoring.
  • Action
    Customers are being advised to immediately implement the revised room temperature operating ranges for the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur CP assays

Device

Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline...
  • Modèle / numéro de série
    Multiple assays used with ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur CP Systems: Theophylline 2, Procalcitonin, Folate, DHEA-SO4, CA 19-9, BR Assay for CA 15-3, BR Assay for CA 27.29, BNP (B-type Natriuretic Peptide), In vitro diagnostic medical devices (IVDs)Theophylline 2ARTG: 175699Procalcitonin, DHEA-SO4ARTG: 175698FolateARTG: 175700BR Assay for CA 15-3, CA 19-9, BR Assay for CA 27.29ARTG: 175636BNPARTG: 175075Multiple SN and REF Numbers
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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