MT20649-1, MT20649-2, MT22719- 1 and MT22719-2

Clinical Chemistry and Clinical Toxicology Devices

It is a glucose monitoring device designed to identify trends and monitor patterns in people of two or more years with diabetes. It is designed to be used by patients in their own home and in health centers. It is an additional device that complements, but replaces, the information obtained from standard glucose monitoring devices to be used at home. It helps to detect episodes of hyperglycemia and hypoglycaemia, allowing to adjust the treatments of acute and chronic cases.

Clinical Chemistry and Clinical Toxicology Devices

PRODUCT USED IN THE LEAD DETECTION PROCESS IN ORIGIN HUMAN SERUM.

Clinical Chemistry and Clinical Toxicology Devices

Determine the different analytes in samples from the human body

Lots: PN5C26 and EA4M78

Clinical Chemistry and Clinical Toxicology Devices

DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION

JM-105, JM-103

Clinical Chemistry and Clinical Toxicology Devices

Used for the measurement of transcutaneous bilirubin (BTC) for the diagnosis of jaundice.

Clinical Chemistry and Clinical Toxicology Devices

Model: models JM103 and JM105, Affected:

Clinical Chemistry and Clinical Toxicology Devices

Clinical Chemistry and Clinical Toxicology Devices

md

Clinical Chemistry and Clinical Toxicology Devices

ivd

Clinical Chemistry and Clinical Toxicology Devices

ivd

Clinical Chemistry and Clinical Toxicology Devices

in-vitro_medical_device

Clinical Chemistry and Clinical Toxicology Devices

in-vitro_medical_device

Clinical Chemistry and Clinical Toxicology Devices

in-vitro_medical_device

Version 4.3.0.8 Release date: 07/31/2009 - Present;  Version 4.3.0.9 Release date: 11/23/2009 - Present;  Version 4.3.0.10 Release date: 09/20/2010- Present;  Version 4.3.0.11 Release date: 11/11/2010- Present;  Version 4.3.0.12 Release date: 02/07/2011- Present; Version 4.3.0.14 Release date: 11/14/2012- Present;  Version 4.3.0.15 Release date: 09/17/2013- Present;  Version 4.4.0.1 Release date: 12/13/2013 - Present;

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distribution US Nationwide and CANADA.

SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0

U14030713, 814031313, U140312323, and U14031413.

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Distribution to the states of FL and OH.

UniStrip1, Blood Glucose Test Strips, 50 count box. || The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

Software Version 3.1 & Below; Serial Numbers J36000101 - J36000834 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Clinical Chemistry and Clinical Toxicology Devices

1

No

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

VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. || 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.

Software Version 3.1 & Below; Serial Numbers J46000108 - J46000492 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Clinical Chemistry and Clinical Toxicology Devices

1

No

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

VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. || The VITROS 4600 Chemistry 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).

Software Version 3.1 & Below; Serial Numbers J56000110 - J56002044 (the serial numbers are sequential; J Numbers are analogous to serial numbers)

Clinical Chemistry and Clinical Toxicology Devices

1

No

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

VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. || 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 4FD085, exp. 12-01-2014

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (nationwide) and country of: Canada.

Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 || Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.

Serial No. 3100 through 7012

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela.

RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. || The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.

DrugCheck Ketamine Dip Test || 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. || This assay provides only a preliminary analytical test result.

Model/Catalog/Part #: 1. cobas b221 <6>=Roche OMNI S6 SYSTEM; and 2. 03337154692 - cobas b 221<6>=Roche OMNI S6 SYSTEM CU Potassium - CEM, Calcium - JFP, Sodium - JGS, Chloride - CGZ, Blood Gases (PCO2, PO2) and pH - CHL, Hemoglobin -GKR, Hematocrit - GKF, Oxygen saturation, Carboxyhemoglobin - GHS, Oxyhemoglobin - GGZ, Methemoglobin - KHG, Deoxyhemoglobin - GKA, Lactic Acid - KHP, Glucose- CGA, Urea Nitrogen - CDS.

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide distribution.

Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present

Clinical Chemistry and Clinical Toxicology Devices

1

No

Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

All Lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe

Beckman Coulter, Lipase Assay, Catalog No. OSR6X30

All Lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe

Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98