Events

Rappel de Dimension EXL Troponin I & Dimension Vista Digoxin, Estradiol, Ferritin, Prolactin and Thyroid Stimulating Hormone

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Siemens Healthcare Diagnostics Inc.

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
    21294
  • Date de mise en oeuvre de l'événement
    2017-10-24
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Cause
    Update 23 october 2017 to march 2017 urgent recall for product correction regarding incorrect units for biotin listed in the non-interfering substances section of select instructions for use in dimension® and dimension vista® assays. ongoing investigation has identified the following new information regarding biotin interference:, 1. biotin interference limits are incorrectly listed in the instructions for use (ifu) for the following assays: dimension tshl, dimension ft4l and dimension vista tsh. concentrations of biotin above the concentration listed in table 2 in the revised biotin non-interference column can potentially result in interference >10%., 2. the dimension vista ctni, mmb, and dimension siro method ifus do not contain biotin interference information. concentrations of biotin above the concentration in the revised biotin non-interference column can potentially result in interference >10%.
  • Action
    Manufacturer to issue advice regarding use

Device

Dimension EXL Troponin I & Dimension Vista Digoxin, Estradiol, Ferritin, Prolactin and Thyroid St...
  • Modèle / numéro de série
    Model: Thyroid Stimulating Hormone (TSHL), LOCI Free Thyroxine (FT4L), Thyroid Stimulating Hormone (TSH), Cardiac Troponin I (CTNI), Mass creatine kinase MB isoenzyme (MMB), Sirolimus (SIRO), All lots (including all future lots until Instructions For Use update), Affected: DM Troponin I (TNI), DV Digoxin (DIGXN), DV Estradiol (E2), DV Ferritin (FERR), DV Prolactin (PRL), DV Thyroid Stimulating Hormone (TSH) All lots including all future lots until instructions of use is updated
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    NZMMDSA