Events

Field Safety Notices about Immunoassay 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
    2015-08-20
  • 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
    We are currently investigating an issue with the products listed below and are providing this urgent field safety notice to inform you of this occurrence. detail on affected devices: immunoassay control ia2640 lot 1364ec and immunoassay premium plus control ia3112 batch 334337 lot 1364ec. description of the problem: pth stability has been reduced in control lot 1364ec. it is now recommended that pth is tested immediately after reconstitution. risk to health: the contents of this letter should be discussed with your medical director. it is unlikely the error will cause misreporting of patient results as values for pth using this lot would fall outside of the assigned ranges. .

Device

Immunoassay Control
  • Model / Serial
    Immunoassay Control – IA2640 – 1364EC Immunoassay Premium Plus Control – IA3112 – 334337 –1364EC
  • Manufacturer
    Randox

Manufacturer

Randox