Events

Field Safety Notices about Dimension® EXL™ integrated chemistry system Dimension Vista® System Dimension EXL TNI, Dimension Vista DIGXN, E2, FERR, PRL, TSH

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Siemens Healthcare Diagnostics Limited.

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
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics has confirmed that the concentrations for biotin listed in the non-interfering substances section of the current dimension and dimension vista instructions for use for dimension tni, dimension vista digxn, e2, ferr, prl, tsh have incorrect units, and incorrectly state the level at which biotin does not interfere. in the cases of tni, e2, ferr, prl, and tsh, there is significant interference at the levels incorrectly stated in the current ifu. dv e2, a competitive assay, exhibits a positive bias while the other methods (sandwich assays) exhibit a negative bias. digxn si units for biotin are incorrect by a factor of 100 lower than the level at which biotin does not interfere, in the current ifu.Dimension (dm) and dimension vista (dv) affected product.

Device

Dimension® EXL™ integrated chemistry system Dimension Vista® System Dimension EXL TNI, Dimension ...

Manufacturer

Siemens Healthcare Diagnostics Limited
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS