Reagent

01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007

Clinical Chemistry and Clinical Toxicology Devices

2

No

The product was shipped nationwide and to Ortho-Clinical/J&J; affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.

VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.

Lot 5140, exp. 4/13/2006; Lot 5150, exp. 5/31/2006; and Lot 5160, exp. 7/3/2006

Immunology and Microbiology Devices

3

No

Nationwide distribution to end users (medical facilities, testing labs and public health agencies). One J&J; foreign affiliate in Puerto Rico with sub-distribution in the Caribbean.

Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit.

list 2K41-20, lot 95567G005, exp 6-30-2006

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and internationally to Canada, Australia, Germany and Taiwan

ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064