Events

Field Safety Notices about Elecsys® Anti-HAV

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 Roche Diagnostics.

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
  • 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
    When li-heparin and na-heparin plasma specimens were compared to serum samples during internal investigations the specified required recovery could not be achieved. values determined with these types of plasma specimens were found to be on average up to 35% below those obtained in serum. false low recovery of samples is likely to occur only for heparin plasma samples within close proximity to the medical decision point of the assay at 20 iu/l. based on internal data generated by testing 4000 blood donors and routine samples approx. 0.1% of samples were close to the cut-off of 20 iu/l. .

Device

Elecsys® Anti-HAV

Manufacturer

Roche Diagnostics