Model Catalog: 1949882 (Lot serial: 1130)

Clinical Chemistry and Clinical Toxicology Devices

VITROS TROPONIN I (TROP I) REAGENT PACK

Model Catalog: 1949882 (Lot serial: 1110)

Clinical Chemistry and Clinical Toxicology Devices

VITROS IMMUNODIAGNOSTIC TROPONIB I REAG

Clinical Chemistry and Clinical Toxicology Devices

In-vitro diagnostics

Lot 611, Exp. 25 June 2004

Clinical Chemistry and Clinical Toxicology Devices

2

No

738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.

Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.

107 2693 | 8350

Clinical Chemistry and Clinical Toxicology Devices

IVD: Buffers (unassignable ), Supplem. Reagents, etc (IC)

Lot 710, Exp. 7/28/05

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide distribution. Product shipped worldwide via J&J; foreign affiliates.

VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

Lots 3151 and 3170

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide-including USA, Canada, and Bermuda

VITROS¿ Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK

Product Code 8379034; Affected Generations (GENs)/Lots: GENs 7 - 13; Expiry Dates: 2013-11-01 thru 2015-01-01

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, France, Italy and Spain.

VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 || VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Clinical Chemistry and Clinical Toxicology Devices

in-vitro_medical_device

01-5871, Exp. 31Jan06

Clinical Chemistry and Clinical Toxicology Devices

2

No

37 U.S. consignees nationwide. Ortho-Clinical foreign affiliates in England, France and Spain.

VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.

01-5919, Exp. 5/31/2005 (EXPIRED):  01-6032, Exp. 9/30/2005 (EXPIRED); and 02-6284, Exp. 1/28/2006

Clinical Chemistry and Clinical Toxicology Devices

2

No

Product shipped to medical facilities (end-users) in the U.S. and to 9 International J&J; affiliates in Australia, Canada, Caribbean, Chile, France, Philippines, Portugal, Taiwan, UK/Northern Europe, Israel, Saudi Arabia and Venezuela.

VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626

VITROS Vapor Adsorption Cartridge. An in vitro diagnostic medical device (IVD).Product codes 6800100 and 1H5419

Clinical Chemistry and Clinical Toxicology Devices

Lot: W 071 6820708

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide distribution: CA

Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 || 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790

list number 9519-02, all lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and internationally to Argentina, Australia, Brazil, Chile, Colombia, Costa Rica, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Mexico, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand, the United Kingdom, Uruguay and Venezuela

XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Sodium Azide as a preservative; 950 mL bottle, 4 bottles per carton; Abbott Laboratories, Abbott Park, IL 60064 USA