Device Recall AxSYM Ultrasensitive hTSH II Master Calibrators

Lot 50082Q100 Exp Date 02/23/2008, Lot 52369Q100 Exp Date 04/20/2008, Lot # 53620Q100 Exp Date 06/26/2008 and Lot # 57518Q100 Exp Date 09/07/2008

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution --- USA including states of AZ, CA, CO, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, WA, WI, WV, and WY, and Puerto Rico, and countries of Canada, Mexico, Brazil, Chile, Germany, Japan, and Hong Kong.

AxSYM Ultrasensitive hTSH II Master Calibrators || Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.