Events

Rappel de N Latex Carbohydrate-deficient Transferrin (CDT). 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-00452-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-04-07
  • 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-00452-1
  • 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 observed lower values for carbohydrate-deficient transferrin (cdt) measurement when using the affected n latex cdt lots in comparison to former lots. cdt results in absolute concentrations are influenced by the patient’s total transferrin levels and therefore results are reported as ratio of cdt to total transferrin, called %cdt. as the transferrin determination with n antiserum to human transferrin is not affected, the lower cdt result leads to calculated %cdt values that show a negative bias of approximately 10 to 15% compared to former lots. this could result in a shift of weak positive patient samples into the reference range of 1.19 – 2.47 %cdt which was derived from a study population of healthy adults. it is not expected that samples from patients with chronic heavy alcohol consumption will be misclassified.
  • Action
    Siemens is advising users to discontinue use of and discard the affected lots. Replacement stock will be provided by Siemens. It is recommended that users review the customer letter with the laboratory Medical Director.

Device

N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).Catalogue Number: OPCS035Siemens Material Number: 10445996Lot Numbers: 45834 & 45987 (Expiry 3 Jun 2017); 46116, 46244, 46388 & 46568 (Expiry 10 Oct 2017)ARTG Number: 178153
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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