Field Safety Notices about QMS® Everolimus Immunoassay

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 Thermo Fisher Scientific.

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
    On august 22, 2016 we sent you the below notice on the qms® everolimus immunoassay. since this letter was sent to you additional information has come to light regarding patient samples. originally in the “reason for field action” section we reported that “current patient samples are not in question.” thermo fisher wishes to update that statement to the following: “you may observe bias in patient samples ranging from -15.7% to +5.2% with an average bias of -5.6% when comparing your assay to the lc-ms reference method”. additionally, thermo fisher is also updating the “risk to health” section. the update clarifies that all ranges (sub-therapeutic, therapeutic, supra-therapeutic) may be affected by as much as 16%. .