Events

Field Safety Notices about Elecsys Vitamin D total II and Vitamin D total II

According to Inspectie Gezondheidszorg en Jeugd, this field safety notices involved a device in Netherlands that was produced by Roche Diagnostics GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2018-05-03
  • Event Country
    Netherlands
  • Event Source
    IGJ
  • Event Source URL
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/05/03/roche-diagnostics-cn-355457---elecsys-vitamin-d-total-ii
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Manufacturer comment
    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