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
    2019-02-10
  • 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 has received customer complaints regarding mol2150 and mol2650 kits. two issues have been reported: 1) first with early cycle threshold (ct) in the sample wells of the direct amplification discs (mol1455, mol1452, mol1451) while performing the mol2150 and mol2650 testing (see figure 1 for some examples of early ct). this error may result in a false negative result, a false positive result or error code(s) 500 or 505. 2) additionally, some customers are reporting insufficient specimen volume errors which may result in higher invalid rates. in those cases, the error results in a report note statement of “insufficient specimen volume”. .

Device

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

Manufacturer

Focus Diagnostics