Device Recall Abbott CELLDYN 3500 Hematology Analyzer CS/SL

  • Modèle / numéro de série
    List numbers: 3500CS: 91340-01, 91340-03; 3500SL: 91350-01, 91350-03.  All serial numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Dominica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand Trinidad and Tobago, Turks & Caicos, Uruguay, and Venezuela.
  • Description du dispositif
    Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca || Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA