Events

Field Safety Notices about Dimension Vista BUN Flex(R) Reagent Cartridge

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia 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 ID
    608
  • Date
    2016-06-22
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

Dimension Vista BUN Flex(R) Reagent Cartridge
  • Model / Serial
    Catalog Number: K1021 Batch Number: Lot # MFG date Exp Date 15341AC 12/7/2015 12/6/2016 15320BB 11/16/2015 11/15/2016 15300BA 10/28/2015 10/26/2016 15299BB 10/27/2015 10/25/2016 15264BA 9/23/2015 10/20/2016 15243BB 8/31/2015 8/30/2016 15215AE 8/4/2015 8/2/2016 June 2016 Update Lot # MFG date Exp Date 16004AB 2016-01-04 2017-01-03 16033AC 2016-02-02 2017-02-01 16034AA 2016-02-02 2017-02-02 16048AA 2016-02-18 2017-02-16 16055AA 2016-02-24 2017-02-23 16055AB 2016-02-25 2017-02-23 16062AA 2016-03-02 2017-03-02 16062AB 2016-03-02 2017-03-02 And Future Dimension Vista BUN lots until further notice
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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