Device Recall SYNCHRON Systems Calibrator 1

  • Modèle / numéro de série
    Lots prior to M005558
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Eritrea, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Poland, Puerto Rico, Qatar Reunion, Russian Federation, Rwanda, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
  • Description du dispositif
    SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 || The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibration of immunoprotein tests on SYNCHRON LX and UniCel DxC Systems.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
  • Source
    USFDA