Devices

Device Recall SmartCycler

  • Modelo / Serial
    All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
  • Descripción del producto
    SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
  • Manufacturer
    Cepheid
  • 1 Event

Fabricante

Cepheid
  • Dirección del fabricante
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA