Events

Field Safety Notices about IL test Magnesium

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

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 Date Posted
    2013-07-08
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/08/07/vazno-obavestenje-o-medicinskom-sredstvu-il-test-magnesium-klinicka-hemija-elektroliti/
  • 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 manufacturer's internal testing has determined that, if the user adheres to the instruction manual that provides the specified pipetting order and the "carryover" logic specified in the user manual for ilab 600/500 and the user manual for ilab taurus, the values obtained for magnesium could be higher than expected. the problem was found to be in carryover, that is, in transferring the reagent between the two analyzes, which is lagging behind on the needle, when the magnesium test is performed as part of a routine job.

Device

IL test Magnesium

Manufacturer

INSTRUMENTATION LABORATORY SPA