Field Safety Notices about QuikRead go® wrCRP and QuikRead go® wrCRP+Hb

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 Orion Diagnostica.

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
  • Event Country
  • Event Source
  • 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
    Orion diagnostica has received complaints on quikfiead go wrcrp (146521, 146522) and quikread go wrcfip+hb (146255) products. our investigations have shown that in rare cases the tests of the below mentioned lots may give either erroneous cfip results or the measurement flow is interrupted by the error message “faulty reagent addition". we are investigating possible effects of improper use and storage of product and manufacturing process.