Events

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

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
    2014-05-15
  • 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 purpose of this letter is to advise you that focus diagnostics is providing an urgent safety notice for a correction to the labeling for simplexa™ flu a/b & rsv direct (mol2650) and simplexa™ hsv 1&2 direct assays (mol2150). focus diagnostics received some customer complaints of simplexa flu a/b & rsv direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and direct amplification disc storage. to date, focus has not received any complaints for the simplexa hsv 1 & 2 direct assay used for commercial use. focus diagnostics is not requesting removal of any products from the test facility, but you should take extra precautions as described in the updated labeling. .

Device

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

Manufacturer

Focus Diagnostics