Ortho-Clinical Diagnostics

T3606, Exp 31 Mar 2004

Clinical Chemistry and Clinical Toxicology Devices

Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).

CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****

Lot 5003, Exp. 12 September 2003

Clinical Chemistry and Clinical Toxicology Devices

Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.

Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793

All slide lots with coatings ''0292'' and ''0293''. The coating lot numbers are seen as ''xxxx-0292-xxxx'' and ''xxxx-0293-xxxx'' in the lot number.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and Worldwide.

Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.

All lots with an expiration date of 1 December 2004 and earlier.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and worldwide distribution to distributors and end-users.

Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]

All lots with an expiration date of 1June 2005 and earlier.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and worldwide distribution to distributors and end-users.

Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month shelf life.]