Device Recall Cepheid Xpert Flu A Panel (GXFLUPANEL10)

  • Modèle / numéro de série
    Lot Numbers: 00401, 00502, 00701, 00702 (Expires 2010 07 11 for lot 00401 and 2010 09 05 for the rest).
  • Classification du dispositif
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
  • Description du dispositif
    Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. || Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • Société-mère du fabricant (2017)
  • Source
    USFDA