Events

Avis De Sécurité sur Stat Profile Prime Analyzers

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 Nova Biomedical Corporation.

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
    2017-06-09
  • 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
    Nova biomedical corporation has recently become aware of a software issue on the stat profile prime analyzers listed above when using stat profile prime auto-cartridge quality control (a-qc) materials (also referred to as “onboard quality control” or “internal quality control”). stat profile prime analyzers that do not utilize auto-cartridge quality control materials are unaffected by this software issue. stat profile prime analyzers that only use traditional external quality control materials (glass ampules) are unaffected by this software issue. .

Device

Stat Profile Prime Analyzers
  • Modèle / numéro de série
    PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG System with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation