Device Recall AxSYM Digoxin III Reagent Pack

  • Model / Serial
    Lot # 46181Q100 Exp.Date 08/10/07, Lot # 50267Q100 Exp.Date 12/16/07
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including States of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, MT, NV, NJ, NY, NC, OH, OK, OR, PA, SD, SC, TN, TX, UT, VA, VT, WA, WI, WY, HI, Puerto Rico, and countries of Canada, Venezuela, Uruguay, Germany, Hong Kong, South Korea, Australia, and New Zealand
  • Product Description
    Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Diagnostic International, Ltd., Carr # 2 Km 58.0, Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA