Events

Field Safety Notices about Premium Plus 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
    2017-07-24
  • 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 that, according to our quality control of the premium plus immunoassay and the premium immunoassay, acth is inconsistent with the reconstituted stability data, such as is listed in the product instructions. it is recommended that acth be analyzed immediately after a 30-minute reconstitution procedure.

Device

Premium Plus control
  • Model / Serial
    IA3109 IA3110 IA3111 IA3112 05055273207255 05055273207262 05055273207279 05055273207286 IA2638 IA2639 IA2640 IA2633 05055273203844 05055273203851 05055273203868 05055273203837
  • Manufacturer
    Randox

Manufacturer

Randox