Events

Rappel de ADVIA Centaur Systems Progesterone Kits

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-2015-RN-00088-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-02-03
  • 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-2015-RN-00088-1
  • 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 a high bias on results greater than 30 ng/ml (95.4 nmol/l) when compared to the master curve when using the affected advia centaur progesterone kit lots. the high bias may cause neat serum samples with results greater than 60 ng/ml (190.8 nmol/l) to recover within the assay range upon dilution (dilution factor applied). on the advia centaur systems, for samples greater than 30 ng/ml (95.4 nmol/l), customers may observe an average dilution recovery between 48.3% and 105.0%. samples (both neat and diluted) with values below 30 ng/ml (95.4 nmol/l) do not demonstrate this bias.Progesterone values above 30 ng/ml (95.4 nmol/l) are indicative of pregnancy. the difference in neat values compared to diluted values will not change the clinical interpretation of the results. siemens advises that the severity of potential injury is negligible and the overall risk to health is negligible to non-existent. no laboratory look back is recommended.
  • Action
    A workaround is provided to customers regarding dilution of samples for lots ending in 268 only. Technical Specialist contact number details are also provided for users as ongoing support. This action has been closed-out on 06/09/2016.

Device

ADVIA Centaur Systems Progesterone Kits
  • Modèle / numéro de série
    ADVIA Centaur Systems Progesterone KitsTest Code: PRGEKit Lot Numbers: Ending in 268Catalogue Numbers: 02382928 (1-pack), 01586287 (5-pack), 02177364 (5-pack Ref)Expiration Date: May 22, 2015ARTG Number: 175698
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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