Events

Field Safety Notices about Lipid Control

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
    2017-08-08
  • 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 acknowledged an error in labeling the lipoprotein (a) target values listed in cat no le2670 lot number 2526ch. printed target values are 62.2 mg / dl and 30 nmol / l. the correct concentrations should be 30 mg / dl and 62.2 nmol / l.

Device

Lipid Control
  • Model / Serial
    LE2670 05055273204209 2526CH 28th Marec 2020 28th April 2017
  • Manufacturer
    Randox

Manufacturer

Randox