Field Safety Notices about Total IgE-HRP EIA

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 Dr. Fooke-Achterrath Laboratorien GmbH.

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
    The control low (control l) and control high (control h) in kit 08102cp total ige-hrp eia with kit lot 1812804cp show different lot numbers on the labels and on the quality control certificate (qcc): labels: 070505l and 070505h qcc: 900505l and 900505h the lot number shown on the qcc is correct for each control. the lot number on the labels is wrong. the functionality of the controls is not affected. they can still be used. the data on the qcc apply. other kit lots are not affected. .