Events

Avis De Sécurité sur DIASTAT ANA ELISA kit

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 Euro Diagnostica AB.

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
  • Date
    2017-02-15
  • 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
    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