Dade Behring, Inc.

Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.

Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.

Part number 1000034941

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.

EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.

Lot numbers: CB9107, DB9093, DB9100, EB9077, EC9077, FC9062, GA9043, GD9069, and GD9087.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. || The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.

Software versions 8.5.1 and 8.5.1SP3.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution including states of AR, CA, CO, IA, ID, IL, IN, LA, MD, MI, MO, MS, NC, NE, OH, OK, PA, SD, TN, TX, VA, and WI.

Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. || The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.