Device Recall ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6pack

  • Modèle / numéro de série
    Lot # Expiry Date  18998A58 06/09/2014; 21854A58 06/09/2014; 25487A59 09/29/2014.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia,Brazil,Canada, Columbia, China, Ecuador, Egypt, India, Japan, Korea, Mexico, Saudi Arabia,Singapore, Thailand, and Uruguay.
  • Description du dispositif
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack || SMN 10314977 || For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
  • Source
    USFDA