Events

Avis De Sécurité sur Elecsys® Anti-HAV

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Roche Diagnostics.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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