Events

Avis De Sécurité sur Captia Syphilis IgG 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 Trinity Biotech.

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
    2016-11-03
  • 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
    Trinity biotech was informed of a customer's concern about the possible under-abundance of red in positive high titre control. the color is not the same with all kits as some vials may be red and some may be colorless. the investigation showed that the color red was fading. in addition, trinity performed performance tests on both red and colorless high titre positive control vials and found that the kit continued to meet all quality assurance criteria for batch release. the absence of color does not affect the performance of a kit that meets all the criteria for performing a valid test. the color red is inert and is usually added for visual distinction.

Device

Captia Syphilis IgG Kit

Manufacturer

Trinity Biotech