Events

Field Safety Notices about TRUEyou Blood Glucose Monitoring System, TRUEyou Blood Glucose Test Strips

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Nipro Diagnostics.

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
    2016-02-05
  • Event Date Posted
    2015-05-25
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2016/05/25/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-trueyou-blood-glucose-monitoring-system-i-trueyou-blood-glucose-test-strips/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The company found that during the on-site packaging process manufacturer for a limited period of time, limited number of boxes closed vials of blood glucose test strips from a particular batch trueresult / trueyou (gdh-fad) may contain an open vial of test strips. test the strips contained within the bottle that remain open for extended periods are exposed to the outside environment, which may affect the characteristics of the test strips.

Device

TRUEyou Blood Glucose Monitoring System, TRUEyou Blood Glucose Test Strips
  • Model / Serial
    E3I60-82FDL - HLS1024ISE; E4ISE70FDL-24 - HLS1024ISE; E4I60- 91FDL - KS1515; E4I60- 91FDL - KS1519
  • Manufacturer
    Nipro Diagnostics

Manufacturer

Nipro Diagnostics