Events

Avis De Sécurité sur Simplexa™ HSV 1 & 2 Direct Simplexa™ Flu A/B & RSV Direct Simplexa™ Group A Strep Direct

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 Focus 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
  • Date
    2016-03-18
  • 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
    Focus diagnostics and 3m (manufacturer of the direct amplification discs [dad]) identified the root cause for the early ct threshold and insufficient specimen volume error to be related to a 3m manufacturing process. an adjustment was made to the equipment and focus and 3m conducted several studies to ensure that the corrective actions taken to address the issues were effective. .

Device

Simplexa™ HSV 1 & 2 Direct Simplexa™ Flu A/B & RSV Direct Simplexa™ Group A Strep Direct

Manufacturer

Focus Diagnostics