Lot Number PN5C26

Clinical Chemistry and Clinical Toxicology Devices

2

No

Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.

arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. || For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.

Catalog Reference #367842; Lot numbers 5089731 and  5175923

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA || The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer¿ Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube.

Catalog Reference #368047; Lot number 5154647

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory.The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.

Catalog Reference #368054; Lot numbers 5089827, 5210514, 5154646, 5210511.  Catalog Reference #367856; Lot number 5064666

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.

Catalog Reference #367855; Lot numbers 5064684, 5120653, 5154643, 5175930, 5210765, 5237787

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.

Catalog Reference #367844; Lot number 5154624  Catalog Reference #367862; Lot numbers 5089771 and 5187753  Catalog Reference #368021; Lot number 5089820

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.

510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates.

iChem 10 SG Urine Chemistry Strips, PN 800-7005. || Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.

Model Number: 933-599 Version 1.8.3

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-US (nationwide) including the states of PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.

AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

Software Version 9.4 and below; VITROS 250 Serial Numbers: 25010043 - 25055306; VITROS 250 Refurbished Serial Numbers: 25010582, 25010617, 25010638, 25010782, 25011056, 25011074, 25011176, 25011192, 25011196, 25011246, 25011317, 25011383, 25011408, 25011435, 25011448, 25011517, 25011647, 25011648, 25011777, 25011957, 25012025, 25012058, 25012062, 25012073, 25012078, 25012140, 25012259, 25012267, 25012323, 25012344, 25012487, 25012505, 25012521, 25012574, 25012629, 25012654, 25012672, 25012765, 25012782, 25012838, 25012931, 25012938, 25013036, 25013100, 25013139, 25013216, 25013245, 25013313, 25013389, 25013391, 25013448, 25013473, 25013497, 25013583, 25013597, 25013719, 25013757, 25013787, 25013790, 25013870, 25013879, 25013971, 25013982, 25014033, 25014196, 25014201, 25014209, 25014272, 25014278, 25014286, 25014318, 25014404, 25014409, 25014412, 25014448, 25014449, 25014459, 25014562, 25014609, 25014610, 25014655, 25014657, 25014663, 25014728, 25014741, 25014775, 25014788, 25014832, 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25016556, 25016557.25016558, 25016563, 25016566, 25016573, 25016580, 25016582, 25016586, 25016589, 25016594, 25016595, 25016596, 25016602, 25016604, 25016613,  25016619, 25016620, 25016637, 25016638, 25016644, 25016647, 25016649, 25016650, 25016670, 25016804, 25016818, 25016837, 25016838, 25016852, 25016899, 25016912, 25016916, 25016917, 25016918, 25016919, 25016932, 25016940, 25016943, 25016944, 25016946, 25016947, 25016950, 25016951, 25016952, 25016953, 25016957, 25016958, 25104774, 27000004, 27000006,  27000007, 27000008, 27000009, 27000010, 27000016, 27000018, 27000022, 27000041, 27000051, 27000052, 27000058, 27000061, 27000063, 27000070, 27000072, 27000075, 27000080, 27000089, 27000103, 27000106, 27000110, 27000112, 27000115, 27000126, 27000133, 27000134, 27000135, 27000136, 27000146, 27000147, 27000148, 27000164, 27000165, 27000175, 27000181,  27000183, 27000192, 27000203, 27000205, 27000206, 27000208, 27000209, 27000217, 27000223, 27000224, 27000227, 27000233, 27000244, 27000273, 27000281, 27000287, 27000289, 27000290, 27000300, 27000303, 27000304, 27000309, 27000313, 27000316, 27000324, 27000326, 27000328, 27000333, 27000350, 27000351, 27000355, 27000357, 27000362, 27000369, 27000372,  27000373, 27000374, 27000382, 27000383, 27000384, 27000389, 27000409, 27000415, 27000418, 27000421, 27000424, 27000427, 27000436, 27000448, 27000450, 27000453, 27000456, 27000457, 27000467, 27000470, 27000471, 27000477, 27000479, 27000483, 27000484, 27000489, 27000492, 27000507, 27000515, 27000516, 27000529, 27000538, 27000540, 27000546, 27000568,  27000581, 27000584, 27000598, 27000606, 27000607, 27000624, 27000627, 27000652, 27000655, 27000658, 27000660, 27000662, 27000663, 27000677, 27000678, 27000680, 27000683, 27000686, 27000696, 27000709, 27000713, 27000714, 27000716, 27000717, 27000718, 27000719, 27000740, 27000745, 27000758, 27000769, 27000777, 27000779, 27000784, 27000787, 27000790,  27000791, 27000796, 27000797, 27000806, 27000813, 27000814, 27000824, 27000835, 27000847, 27000854, 27000861, 27000862, 27000869, 27000872, 27000873, 27000874, 27000875, 27000877, 27000880, 27000881, 27000882, 27000894, 27000903, 27000908, 27000912, 27000924, 27000926, 27000927, 27000928, 27000930, 27000947, 27000948, 27000949, 27000958, 27000961, 27000963, 27000964, 27000984, 27000988, 27000994, 27001005, 27001006, 27001007, 27001021, 27001032, 27001061, 27001066, 27001087, 27001089, 27001091, 27001093, 27001094, 27001103, 27001104, 27001123, 27001139, 27001144, 27001145, 27001166, 27001167, 27001170, 27001177, 27001183, 27001185, 27001187, 27001193, 27001202, 27001205, 27001212, 27001213, 27001221, 27001223, 27001229, 27001234, 27001236, 27001240, 27001241, 27001279, 27001283, 27001289, 27001304, 27001319, 27001326, 27001334, 27001337, 27001353, 27001360, 27001361, 27001364, 27001366, 27001381, 27001400, 27001402, 27001418, 27001426, 27001429, 27001434, 27001448, 27001473, 27001497, 27001520, 27001524, 27001525, 27001526, 27001531,  27001533, 27001535, 27001552, 27001556, 27001559, 27001565, 27001599, 27001612, 27001639, 27001645, 27001646, 27001647, 27001660, 27001662, 27001667, 27001670, 27001692, 27001693, 27001694, 27001696, 27001698, 27001729, 27001741, 27001766, 27001772, 27001785, 27001796, 27001802, 27001806, 27001871, 27001901, 27001905, 27001912, 27001934, 27001952,  27001953, 27001968, 27001975, 27002013, 27002018, 27002028, 27002044, 27002134, 27002136, 27002151, 27002183, 27002245, 27002304, 27002350, 27002352, 27002521, 27002526, 27002557, 27002652, 27002663, 25010717A, R2500004, R2500011, R2500028, R2500033, R2500037, R2500041, R2500044, R2500050, R2500063, R2500081, R2500087, R2500125, R2500140, R2500146, R2500147, R2500149, R2500155, R2500158, R2500173, R2500183, R2500188, R2500189, R2500191, R2500232

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 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. || Product Usage: || For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

The EVOLIS Microplate System instrument is not lot controlled, however for traceability purposes each instrument is assigned a unique serial number.  SERIAL NUMBERS:  9163700126, 9163700175, 9163700187, 9163700196, 9163700208, 9163700210, 9163700231, 9163700266, 9163700278, 9163700320, 9163700328, 9163700336, 9163700337, 9163700349, 9163700354, 9163700368, 9163700402, 9163700431, 9163700449, 9163700478, 9163700480, 9163700481, 9163700495, 9163700498, 9163700499, 9163700501, 9163700510, 9163700527, 9163700530, 9163700531, 9163700544, 9163700556, 9163700558, 9163700559, 9163700560, 9163700567, 9163700585, 9163700587, 9163700594, 9163700595, 9163700623, 9163700624, 9163700625, 9163700629, 9163700656, 9163700695, 9163700696, 9163700722, 9163700743, 9163700744, 9163700745, 9163700764, 9163700765, 9163700772, 9163700775, 9163700776, 9163700810, 9163700821, 9163700822, 9163700823, 9163700835, 9163700836, 9163700843, 9163700844, 9163700846, 9163700850, 9163700851, 9163700853, 9163700855, 9163700857, 9163700862, 9163700863, 9163700864, 9163700868, 9163700873, 9163700874, 9163700875, 9163700877, 9163700879, 9163700883, 9163700884, 9163700885, 9163700887, 9163700888, 9163700889, 9163700890, 9163700891, 9163700892, 9163700893, 9163700895, 9163700898, 9163700899, 9163700901, 9163700902, 9163700906, 9163700907, 9163700909, 9163700910, 9163700911, 9163700912, 9163700913, 9163700914, 9163700916, 9163700917, 9163700918, 9163700919, 9163700920, 9163700921, 9163700922, 9163700926, 9163700927, 9163700928, 9163700929, 9163700930, 9163700931, 9163700932, 9163700933, 9163700934, 9163700935, 9163700936, 9163700937, 9163700938, 9163700939, 9163700941, 9163700942, 9163700943, 9163700945, 9163700946, 9163700947, 9163700948, 9163700949, 9163700950, 9163700952, 9163700956, 9163700957, 9163700959, 9163700960, 9163700961, 9163700962, 9163700964, 9163700965, 9163700966, 9163700967, 9163700968, 9163700972, 9163700973, 9163700974, 9163700975, 9163700977, 9163700978, 9163700979, 9163700980, 9163700981, 9163700982, 9163700984, 9163700985, 9163700987, 9163700988, 9163700989, 9163700991, 9163700992, 9163700993, 9163700996, 9163700997, 9163700998, 9163700999, 9163701000, 9163701001, 9163701002, 9163701003, 9163701004, 9163701005, 9163701006, 9163701007, 9163701008, 9163701009, 9163701010, 9163701011, 9163701012, 9163701013, 9163701014, 9163701015, 9163701017, 9163701018, 9163701019, 9163701020, 9163701021, 9163701022, 9163701023, 9163701024, 9163701025, 9163701026, 9163701027, 9163701028, 9163701029, 9163701030, 9163701031, 9163701032, 9163701033, 9163701034, 9163701035, 9163701036, 9163701037, 9163701038, 9163701039, 9163701040, 9163701041, 9163701042, 9163701043, 9163701044, 9163701045, 9163701046, 9163701047, 9163701048, 9163701049, 9163701051, 9163701052, 9163701053, 9163701054, 9163701056, 9163701057, 9163701058, 9163701059, 9163701060, 9163701061, 9163701063, 9163700168R, 9163700172R, 9163700176R, 9163700202R, 9163700206R, 9163700209R, 9163700215R, 9163700221R, 9163700234R, 9163700236R, 9163700242R, 9163700246R, 9163700247R, 9163700276R, 9163700281R, 9163700282R, 9163700293R, 9163700294R, 9163700296R, 9163700326R, 9163700327R, 9163700330R, 9163700355R, 9163700359R, 9163700397R, 9163700398R, 9163700400R, 9163700432R, 9163700479R, 9163700494R, 9163700562R, 9163700563R, 9163700564R, 9163700565R, 9163700573R, 9163700617R, 9163700811R, 9163700834R, 9163700837R, 9163700878R, 9163700881R, 9163700886R, 9163700904R, 9163700908R, 9163700915R, 9163700925R, 9163700951R, 9163700958R, 9163700969R, 9163700971R, 9163700986R, and 916370726R.

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Nationwide Distribution including Puerto Rico.

EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic || Product Usage: || EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.

All Lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.

The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.

All Lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.

ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.

All Lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.

ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.

All Lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.

ABX PENTRA Lactic Acid CP ref. A11A01721 || reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

All Lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.

ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.

All Lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.

ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method).

Software Version 9.4 and below; Serial Numbers J27000001 - 27004539

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 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. || Product Usage: || For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

Software Version 3.2 and below; Serial Numbers J46000001 - 46000678

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, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. || Product Usage: || For in vitro diagnostic use. 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 3.2 and below; Serial Numbers J56000024 - 56002339

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 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. || 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.

Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000119 - J34002323; VITROS 5,1 FS Chemistry System (Refurbished) Serial Numbers: 34000133, 34000193, 34000197, 34000212,  34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557,  34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799,  34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006,  34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274,  34001297, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850,  34001875, 34001897, 34000123, 34000143, 34000191, 34000215, 34000219,  34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431,  34000454, 34000464, 34000473, 34000501, 34000523, 34000530, 34000541,  34000542, 34000546, 34000548, 34000553, 34000558, 34000576, 34000577, 34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617,  34000618, 34000620, 34000625, 34000637, 34000644, 34000672, 34000744,  34000745, 34000755, 34000759, 34000767, 34000776, 34000793, 34000800, 34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870,  34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938,  34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045,  34001052, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129,  34001154, 34001161, 34001171, 34001182, 34001192, 34001195, 34001201,  34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271,  34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301,  34001302, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367,  34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423,  34001427, 34001429, 34001457, 34001490, 34001518, 34001526, 34001551, 34001573, 34001580, 34001581, 34001582, 34001587, 34001589, 34001594,  34001610, 34001618, 34001623, 34001627, 34001673, 34001688, 34001693,  34001725, 34001738, 34001745, 34001747, 34001790, 34001796, 34001798,  34001810, 34001822, 34001831, 34001833, 34001849, 34001855, 34001859,  34001860, 34001867, 34001871, 34001872, 34001881, 34001905, 34001916,  34001923, 34001995

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 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. || Product Usage: || The VITROS 5,1 FS 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.)

All lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.

Siemens ADVIA Centaur Enhance Estradiol || Test Code eE2 || Catalog Number: 10490889, 10491445, 10697757 || Product Usage: || For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.

All lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.

Dimension Vista LOCI Estradiol || Test Code E2 || Catalog Number: K6463 || SMN: 10489099 || Product Usage: || The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

All lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.

IMMULITE 1000 Estradiol || Test Code E2 || Catalog Number: LKE21, LKE21(D), LKE25 || SMN: 10381132, 10702832, 10381142 || Product Usage: || For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal sexual disorders

All lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.

IMMULITE 2000 EstradiolTest Code E2 || Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) || SMN: 10381178, 10702833, 10381177, 10702834 || Product Usage: || For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders

all serial numbers

Clinical Chemistry and Clinical Toxicology Devices

1

No

Affected geographies: Argentina, Australia, Austria, Bangladesh, Bermuda, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico , Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic, United States (including Puerto Rico), and Venezuela

iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 || iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001