Events

Field Safety Notices about Level 3 urine test fluid

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 Randox.

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
    2017-04-20
  • 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
    Randox found an error in labeling for two of the above test methods for determining the amount of total protein (in urine). the values for the mean of all instruments are incorrect by a factor of 10. the correct values are given in the table below. the latter does not affect the performance and stability data of the product. instrument-specific values are correct.

Device

Level 3 urine test fluid
  • Model / Serial
    UC5075 05055273207576 907UC 28. 6. 2019 13. 12. 2016
  • Manufacturer
    Randox

Manufacturer

Randox