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

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

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

Clinical Chemistry and Clinical Toxicology Devices

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

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.

Clinical Chemistry and Clinical Toxicology Devices

in-vitro_medical_device

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.

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

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.

107 2693 | 8350

Clinical Chemistry and Clinical Toxicology Devices

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

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.

Clinical Chemistry and Clinical Toxicology Devices

In-vitro diagnostics

Model Catalog: 1949882 (Lot serial: 3151); Model Catalog: 1949882 (Lot serial: 3170)

Clinical Chemistry and Clinical Toxicology Devices

SEE 33-01

Model Catalog: 1949882 (Lot serial: 1110)

Clinical Chemistry and Clinical Toxicology Devices

VITROS IMMUNODIAGNOSTIC TROPONIB I REAG

Model Catalog: 1949882 (Lot serial: 1130)

Clinical Chemistry and Clinical Toxicology Devices

VITROS TROPONIN I (TROP I) REAGENT PACK

Model Catalog: 8633893 (Lot serial: C/N 30000755)

Clinical Chemistry and Clinical Toxicology Devices

VITROS ECI IMMUNODIAGNOSTIC ANALYZER

Catalog# 6802331 Lot# M5620

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic

Catalog# 6802330 Lot# L5619

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

Catalog# 6802329 Lot# K5618

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic

Catalog# 6802328 Lot# J5617

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic

Catalog# 6802327 Lot# H5616

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

VITROS Chemistry Products DAT Performance Verifier I || in vitro diagnostic

Lot # 1529-17-2636, expiration date 12 June 2013

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.

VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. || Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

Lots 1400 (exp. 22 April 2013), 1410 (exp. 20 May 2013), 1420 (exp. 12 July 2013), 1430 (exp. 5 August 2013) , 1440 (exp. 10 September 2013), 1450 (exp. 18 November 2013), 1460 (exp. 18 November 2013), 1465 (exp. 13 November 2013), 1480 (exp. 3 January 2014)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.

VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK || For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin).

Current/In-date GENs 26, 27, 28, 29, 31

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.

VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- || For in vitro diagnostic use only.

Current/In-date GENs 16, 17, 19, 20, 22, 23, 24, 25, 27 through 32

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.

VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD --- || For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders