Events

Field Safety Notices about DIASTAT ANA ELISA kit

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 Euro Diagnostica AB.

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
    2017-02-15
  • 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 reason for this field safety notice is that the affected kit lot ts 2076 of diastat ana elisa is at risk of malfunctioning due to an unstable conjugate. testing of retain material at euro diagnostica with a sample panel from healthy donors showed that there was an increased risk for equivocal sample results with the ana lot ts 2076. investigation suggests that the igg conjugate is unstable over time and the shelf-life of the product cannot be guaranteed. there is a risk that users get false positive test results. this is a product malfunction. however based on the product information to customers, there is a risk that treatment may be started up based on a false positive result, which could be critical for patient health and safety. .

Device

DIASTAT ANA ELISA kit

Manufacturer

Euro Diagnostica AB