Events

Field Safety Notices about Dimension Vista® System

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 Inc..

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 determined that dimension vista® ammonia (amm) lots 16187be, 16225bb, and 16265ab do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay [e143] message. these lots may exhibit accuracy shifts for quality control and/or patient results (table 2) which may cause laboratories to recalibrate more frequently than the 60-day claim in the instructions for use (ifu). siemens and the reagent supplier are conducting additional testing to monitor stability for newer reagent lots to ensure no other lots are impacted. .

Device

Dimension Vista® System
  • Model / Serial
    Ammonia AMM 16187BE 2017-07-05 2016-08-04 K3119 10711992 16225BB 2017-08-12 2016-09-12 16265AB 2017-09-21 2016-10-11
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

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