Device Recall Dimension Flex Reagent Cartridge Cardiac TropininI

Lot numbers: GF7353 exp 12/19/07, FF7362 exp 12/28/07, and GE7353 exp 12/19/07.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- USA, Canada, Germany, Egypt, New Zealand, Saudi Arabia, Singapore, and BS.

Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521. || Intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk or mortality.