Events

Rappel de Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analysers. 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 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-2013-RN-00915-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-30
  • 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-2013-RN-00915-1
  • 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 immulite/ immulite 1000/ immulite 2000 and immulite 2000 xpi free t3 assay kit lots listed with adjustor (lf3l/h) lot #135 are showing an elevated shift in patient values that exceed the upper limits of the normal reference range referenced in the immulite free t3 instructions for use (ifu). the elevated immulite free t3 results will not correlate with the results of other thyroid markers or free t3 results generated on other platforms.
  • Action
    Siemens is requesting their customers to cease using the affected lots of reagent. Replacement with unaffected lots can be arranged to replace any stock. A look back of previously reported results is not recommended by Siemens as the assessment of thyroid function is generally based on multiple markers. However, the requirement for a look back should be determined at the discretion of the laboratory. Thia action has been closed-out on 29/01/2016.

Device

Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analys...
  • Modèle / numéro de série
    Free T3 Assays for use on the IMMULITE, IMMULITE 1000, IMMULITE 2000 and IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD).IMMULITE/IMMULITE 1000 FT3Catalog Number: LKF31Siemens Material Number: 10381626Lot Numbers: 353 & 354IMMULITE 2000/IMMULITE 2000 XPi FT3Catalog Numbers: L2KF32 & L2KF36Siemens Material Numbers: 10381675 & 10381682Lot Numbers: 737, 738, 739, 740, 741, 742 & 743ARTG number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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