IMMULITE

All units.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Software was distributed to Immulite 2000 users throughout the nation. These units are found in hospitals and clinics. Software was also distributed to the firm''s service representatives.

Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.

Lot 118

Immunology and Microbiology Devices

1

No

US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria

Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)

Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)

Clinical Chemistry and Clinical Toxicology Devices

2

No

North America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital, St. Louis MO VA Medical Center, Denver, CO VA Medical Center, Richmond, VA VA Medical Center, West Haven, CT Walter Reed Army Medical Center, Washington DC

IMMULITE 2000 Intact PTH kit

Lots 5 157 and 5 157L

Immunology and Microbiology Devices

2

No

Immulite 1000 CEA || Catalog No. LKCE1

IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.

Clinical Chemistry and Clinical Toxicology Devices

2

No

AL, CA, CO, FL, IL, KS, LA, NY, MA, MD, MI, MS, NC, NE, NM, OH, PA, TN, TX, UT, WA, and Australia, Czech Republic, France, Germany, Netherlands, Portugal, Puerto Rico, Sweden, Turkey, UK, Venzuela

IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.