Events

Rappel de N Latex 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-2018-RN-00645-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-01
  • 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-2018-RN-00645-1
  • 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 a negative bias for the carbohydrate-deficient transferrin (cdt) measurement when using the affected n latex cdt lots in comparison to the hplc method.Cdt results in absolute concentrations may be influenced by patient’s 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 observed effect leads to calculated %cdt values that show a negative bias of approximately 15% compared to the hplc method. 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.
  • Action
    Siemens Healthcare Diagnostics has assigned optimised values to the affected lots of standards and controls included in the kit lots. Those lots of standards and controls can be used with the revised assigned values and acceptance ranges. Siemens is advising users to: · Recalibrate their CDT method with N CDT Standard lots listed in the Customer Letter, using the revised assigned values provided in the communication. · Use the revised assigned values and respective ranges of the N CDT Controls provided in the Customer Letter. · For BN ProSpec and Atellica NEPH 630 customers, a new Lot Data CD as well as new Secure Download Files are expected to be available in June 2018 including the revised CDT target values for N CDT Standard, N CDT Control 1 and N CDT Control 2. · Ensure that the values manually entered according to the Customer Letter are not overwritten by using an older Lota Data CD/Secure Download File afterwards.

Device

N Latex CDT. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    N Latex CDT. An in vitro diagnostic medical device (IVD)Catalogue Number: OPCS03Material Number: 10445996Lot Numbers: 47167, 47168, 47430, 47431, 47433, 47597, 47642, 47727, 47848, 48013, 48014, 48118 & 48169ARTG number: 178153(Siemens Healthcare - Clinical chemistry-specific protein IVDs)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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