Devices

Device Recall SmartCycler

  • Modèle / numéro de série
    All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
  • Description du dispositif
    SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
  • Manufacturer
    Cepheid
  • 1 Event

Fabricant

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