Field Safety Notices about EliA CCP Assay

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
    We informed you in fsn2016-02 that, when using elia ccp well in combination with elia igg conjugate, anti-ccp-signals are elevated for new conjugate lots. elia ccp well: (14-5515-01, 14-5515-41, 14-5515-03, 14-5515-10) elia igg conjugate: (83-1017-01, 83-1017-41, 83-1005-01, 83-1005-41, 83-1002-01, 83-1002-41 or 83-1018-01, 83-1018-41) solution of the problem: we will release new lots of elia ccp well that are optimized to the performance of currently available and future lots of elia igg conjugate. to ensure non-elevated assay performance these new elia ccp well lots must not be combined with old elia igg conjugate lots and old elia ccp positive control lots, as illustrated below. details on lot numbers can be found in table 1 and 2 in this field safety notice.