Events

Field Safety Notices about Liquid Cardiac 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
    2017-02-17
  • 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 has confirmed a change in recovery with regards to myoglobin in the lots of the liquid cardiac control listed above for the randox lmmunoturbidimetric method. internal testing of the affected lots has shown an increased rate of degradation for myoglobin only. new targets and control ranges have therefore been assigned for the randox immunoturbidimetric method.

Device

Liquid Cardiac Control
  • Model / Serial
    Myoglobin CQ5051 05055273207446 3909CK 28‘“ Oct 17 10‘“ Nov 15 3910CK 28““ Oct 17 10'“ NOV 15 3913CK 28”" Oct 17 10‘“ Nov 15 cososz 05055273207453 3911CK 28““ Oct 17 ' 30““ Oct 15 3990CK 23‘“ Apr 18 13‘“ May 16 3991CK 28‘“ Apr 18 13‘“ May 16 3992CK 28‘“ Apr 18 13‘“ May 16 c05053 05055273207460 3912CK 28‘“ Oct 17 9‘“ Nov 15
  • Manufacturer
    Randox

Manufacturer

Randox