Events

Field Safety Notices about Magnesium – MG8326 – RX Daytona Plus

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 Laboratories Ltd.

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
    2016-03-15
  • 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
    It has been discovered that there is reagent probe carryover from amylase to magnesium on the rx daytona plus which can cause elevated magnesium results. this will only occur if magnesium directly follows amylase. implementation of an acid wash before magnesium removes the carryover effects. .

Device

Magnesium – MG8326 – RX Daytona Plus
  • Model / Serial
    cobas® EGFR Mutation Test, v2 CE-IVD cobas® cfDNA Sample Preparation Kit IVD GMMI / Part No Device Identifier cobas® EGFR Mutation Test, v2 CE-IVD GMMI: 07248563190 UDI: 00875197005448 cobas® cfDNA Sample Preparation Kit IVD GMMI: 07247737190 UDI: 00875197005424
  • Manufacturer
    Randox Laboratories Ltd

Manufacturer

Randox Laboratories Ltd