VITROS

All VITROS¿ 3600 Systems Catalog # 6802783 that have not been eConnected which may have Assay Data Disk (ADD) Data Release Version (DRV) 9241 or 9251. J/Serial Numbers: 36000206, 36000268, 36000269, 36000290, 36000319, 36000404, 36000414, 36000416, 36000426,  36000430, 36000453, 36000464, 36000466, 36000467, 36000475, 36000143, 36000151, 36000152, 36000159, 36000165, 36000187, 36000194, 36000198, 36000204, 36000222, 36000228, 36000257, 36000258, 36000271, 36000275, 36000279, 36000301, 36000306, 36000307, 36000313, 36000315, 36000322, 36000324, 36000325, 36000326, 36000327, 36000330, 36000332, 36000333, 36000335, 36000336, 36000338, 36000342, 36000347, 36000348, 36000352, 36000353, 36000355, 36000360, 36000364, 36000365, 36000372, 36000374, 36000382, 36000384, 36000389, 36000390, 36000391, 36000392, 36000394, 36000395, 36000400, 36000401, 36000403, 36000405, 36000408, 36000421, 36000422, 36000425, 36000429, 36000431, 36000434, 36000438, 36000441, 36000442, 36000443, 36000448, 36000461, 36000462, 36000468, 36000469, 36000470, 36000471, 36000472, 36000473, 36000476, 36000477, 36000478, 36000479, 36000481, 36000483. -- NOTE: VITROS¿ 3600 that are e-Connected are not affected by this issue.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (nationwide) including the countries of: Brazil, Canada, Chile, China, England, France, Germany, India, Italy, Japan, Mexico, Singapore, Spain and Venezuela.

VITROS¿ 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS¿ 3600 --- NOTE: VITROS¿ 3600 that are e-Connected are not affected by this issue. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS¿ Immunodiagnostic Products Reagents.

All VITROS¿ 5600 Systems Catalog # 6802413 that have not been eConnected which may have Assay Data Disk (ADD) Data Release Version (DRV) 9241 or 9251. J/Serial Numbers: 56000395, 56000482, 56000497,  56000511, 56000514, 56000524, 56000553, 56000607, 56000608, 56000770, 56000776, 56000777, 56000778, 56000824, 56000825, 56000826, 56000827, 56000835, 56000840, 56000841, 56000843, 56000888, 56000892, 56000902, 56000905, 56000927, 56000954, 56000955,  56000974, 56000976, 56000987, 56000990, 56000994, 56000122,  56000124, 56000133, 56000138, 56000187, 56000220, 56000223, 56000286, 56000288, 56000329, 56000353, 56000358, 56000429, 56000431, 56000455, 56000465, 56000487, 56000526, 56000627, 56000664, 56000672, 56000673, 56000674, 56000677, 56000683, 56000685, 56000715, 56000716, 56000723, 56000725, 56000726, 56000730, 56000732, 56000733, 56000734, 56000735, 56000739, 56000754, 56000760, 56000761, 56000762, 56000763, 56000765, 56000766, 56000767, 56000784, 56000789, 56000791, 56000799, 56000804, 56000805, 56000806, 56000807, 56000808, 56000809, 56000828, 56000829, 56000834, 56000862, 56000868, 56000869, 56000870, 56000897, 56000899, 56000916, 56000917, 56000922, 56000931, 56000940, 56000944, 56000946, 56000947, 56000949, 56000956, 56000960, 56000969, 56000986, 56000988, 56000989, 56000998, 56001003, 56001005, 56001006, 56001009, 56001014, 56001017, 56001018, 56001020, 56001030, 56001034, 56001035, 56001036, 56001037, 56001038, 56001039, 56001040, 56001044, 56001045, 56001050. --- NOTE: VITROS¿ 5600 that are e-Connected are not affected by this issue.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (nationwide) including the countries of: Brazil, Canada, Chile, China, England, France, Germany, India, Italy, Japan, Mexico, Singapore, Spain and Venezuela.

VITROS¿ 5600 Integrated Systems, Catalog # 6802413; COMMON/USUAL NAME: VITROS¿ 5600 --- NOTE: VITROS¿ 5600 that are e-Connected are not affected by this issue. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS¿ Immunodiagnostic Products Reagents.

Product code: 6802413; Serial numbers: 56000118 - 56001498

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US (nationwide)

VITROS 5600 Integrated System Software Version 1.6 & Below || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

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).