Device Recall ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2pack

  • Model / Serial
    Lot # Expiry Date  19002A58 06/09/2014; 19088A58 06/09/2014; 21376A58 06/09/2014; 25657A59 09/29/2014; 26830A59 09/29/2014; 28447A59 09/29/2014.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack || SMN 10311391 || 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

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Manufacturer Parent Company (2017)
  • Source
    USFDA