Events

Field Safety Notices about Anti-Jka (JK1)

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 Medical Diagnostics 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
    2016-01-25
  • 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
    The above mentioned product showed a reactivity decrease after approximately 9 months shelf life for the lot number listed above. weak or false negative results might be possible in testing. the problem is caused by the human raw material. it is well known that raw material of human source might lose the reactivity during the expected shelf life. already given test results can be taken, when the recommended positive and negative controls were tested in parallel and showed the expected results. .

Device

Anti-Jka (JK1)

Manufacturer

Bio-Rad Medical Diagnostics GmbH