Device Recall Unicel Synchron Clinical Systems

  • Modèle / numéro de série
    All Serial Numbers
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA: including the states of AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, AND WV and the country of Canada.
  • Description du dispositif
    Closed Tube Aliquotter (CTA) for UniCel || DxC 600i, Part Number: A25637, Domestic; A25633, International || The UniCel Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
  • 2 Events

Fabricant

  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
  • Source
    USFDA