Events

Avis De Sécurité sur Elecsys Vitamin D total II and Vitamin D total II

Selon Inspectie Gezondheidszorg en Jeugd, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Netherlands qui a été fabriqué par Roche Diagnostics GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2018-05-03
  • Pays de l'événement
    Netherlands
  • Source de l'événement
    IGJ
  • URL de la source de l'événement
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/05/03/roche-diagnostics-cn-355457---elecsys-vitamin-d-total-ii
  • Notes / Alertes
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notes supplémentaires dans les données
  • Cause
    In this update, we would like to inform you that the issue occurs only with plasma samples and we provide you with an updated workaround. serum samples are not affected and can be measured without workaround. irrespective of the sample type, we would like to remind you of the importance of pre-analytical handling and sample quality when running elecsys vitamin d total ii. during the implementation of the elecsys vitamin d total ii assay on modular analytics e 170, cobas e 601 and cobas e 602 systems, customers reported non-reproducible, false high results.

Device

Elecsys Vitamin D total II and Vitamin D total II

Manufacturer

Roche Diagnostics GmbH
  • Société-mère du fabricant (2017)
    Roche Holding Ag
  • Commentaire du fabricant
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ