Events

Rappel de ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. 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-2017-RN-00488-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-21
  • 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-2017-RN-00488-1
  • 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
    An internal investigation by siemens has identified that certain lots of the advia centaur systems insulin (iri) assay recover approximately 40% higher than the world health organisation (who) 1st irp 66/304 standardisation based on slope values. the slope value was observed to be 1.40 on the advia centaur xp and 1.42 on the advia centaur cp. the potential exists for misinterpretation of insulin levels when comparing to the who standard. siemens has confirmed that the assay’s reportable range, reference interval, precision, analytical sensitivity, hook effect and linearity are not impacted by this issue and continue to meet the assay performance characteristics as stated in the instructions for use.
  • Action
    Siemens is advising users that standardisation to WHO 1st IRP 66/304 has been restored beginning with ADVIA Centaur IRI ReadyPack kit lots ending in 201 and IRI Calibrator kit lots ending in 02, which will be available by May 2017. In the interim, users can continue to use existing product to report results and should ensure that clinicians are made aware that results will be approximately 40% higher than the WHO 1st IRP 66/304 material. Upon receipt of ADVIA Centaur Systems Insulin ReadyPack kit lots ending in 201 (and future lots) and IRI Calibrator kit lots ending in 02 (and future lots), users are discontinue use of the affected product. The Bio-Rad website should be referred to for revised control targets and ranges to be used with corrected product. For all other commercially available controls, evaluate the need for target reset. Further details regarding expected performance are detailed in the customer letter.

Device

ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. An in vitro diagnostic medical device ...
  • Modèle / numéro de série
    ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. An in vitro diagnostic medical device (IVD)Insulin CalibratorTest Code: Calibrator IRICatalogue #: 04618899SMN: 10310438Kit Lots ending in: 59 (exp 05 Apr 17), 67 (exp 22 Aug 17), 70 (exp 27 Nov 17), 74 (exp 26 Feb 17)Insulin ReadyPackTest Code: IRICatalogue #: 02230141SMN: 10310439Kit Lots ending in: 169 (exp 11 Apr 17), 170 (exp 27 May 17), 173 (exp 30 Jun 17), 174 (exp 26 Aug 17)ARTG Number: 175698
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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