Device Recall XSYSTEMS Quinidine Controls

  • Modèle / numéro de série
    Lot # 44161Q100 Exp. Date: 08/23/2007,  Lot # 46295Q100 Exp. Date: 8/23/2007,  Lot # 48239Q100 Exp. Date: 01/04/2008, and Lot# 50238Q100 Exp. Date: 05/20/2008
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS
  • Description du dispositif
    XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent concentration ranges.-Product List Number 9506-10
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Diagnostic International, Ltd., 30 Bo Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA