Dimension

Lot number GB9021 exp 2009-01-21 and Lot number GB9029 exp 2009-01-29

Immunology and Microbiology Devices

3

No

The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE

Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714

Part Number: 1000046623.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, Portugal, Slovenia, Spain and Switzerland.

EasyLink Informatics System included with the Dimension Vista System. || The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

Lot number 09061AA exp 2010-03-02

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea.

Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.

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.

Lot Number 9DM001

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia.

Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 || The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), || Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System