Ortho-Clinical Diagnostics

Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Medical facilities nationwide and 1 foreign affiliate in Canada.

VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy.

Catalog # 6802159

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France.

VITROS¿ WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.

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.

All enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.

enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- For in vitro diagnostic use only. || The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).