Events

Field Safety Notices about DiaMed Q.C. System

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 Bio-Rad Laboratories.

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
    2017-10-05
  • 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 would like to inform you about the replacement related to the issue we had with the product diamed q.C. system, ihd lot n° 45950 46 1, 45950 47 1 and 45950 48 1 showing hemolysis in samples 1 and 4 and weakly in sample 2 according to pqn 2017-07, sent out on 06 th of september. .

Device

DiaMed Q.C. System
  • Model / Serial
    DiaMed Q.C. System 009930 45950 46 1 166035461 25.09.2017 45950 47 1 172383471 09.10.2017 45950 48 1 174297481 23.10.2017 45950 49 1 180341491 06.11.2017 45950 50 1 180343501 06.11.2017
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories