Device Recall AxSYM Digoxin II Reagent Pack.

Lot 61275Q100, exp. date: 09/09/08; Lot 58167Q100, exp. date: 08/30/08; Lot 56039Q101, exp. date: 07/13/08; and Lot 56039Q100, exp. date: 07/13/08.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution --- USA including states of AL, AZ, AR, CA, CT, FL, GA, IL, KS, MD, MA, MI, MN, MS, MO, NV, NJ, NY, ND, OK, OR, PA, RI, TX, VA, WA, Hawaii, and Puerto Rico, and countries of Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Chile, Uruguay, Argentina, Puerto Rico, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand, Curacao, and Panama.

AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) || The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy.