Device Recall VITROS 5,1 FS Chemistry System

Software Versions 2.2.1 through 2.8; Catalog # 6801375 Serial Numbers: 34000119 through 34002323; Catalog # 6801890 Serial Numbers: J34000133, J34000193, J34000197, J34000212, J34000285, J34000316, J34000318, J34000337, J34000360, J34000420, J34000451, J34000478, J34000495, J34000497, J34000529, J34000538, J34000552, J34000557, J34000590, J34000596, J34000601, J34000631, J34000642, J34000761, J34000799, J34000805, J34000833, J34000851, J34000893, J34000946, J34000947, J34001006, J34001172, J34001218, J34001240, J34001243, J34001248, J34001251, J34001274, J34001297, J34001311, J34001317, J34001345, J34001378, J34001379, J34001389, J34001390, J34001396, J34001422, J34001472, J34001504, J34001569, J34001572, J34001612, J34001626, J34001633, J34001668, J34001755, J34001809, J34001840, J34001850, J34001875, J34001897.

Clinical Chemistry and Clinical Toxicology Devices

1

No

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

VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD --- Ortho Clinical Diagnostics Inc. || The VITROS 5,1 FS Chemistry System with enGEN 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.)

Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers J34000016 - 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, 34001311, 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, 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 and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, 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, Software Version 2.8 and below, 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.).

VITROS 5,1 FS Chemistry System Serial Numbers: 34000119 through 34002273; VITROS 5,1 FS Chemistry System Refurbished Serial Numbers: 34000133, 34001240, 34000193, 34001243, 34000212, 34001248, 34000316, 34001251, 34000318, 34001274, 34000337, 34001297,  34000360, 34001311, 34000420, 34001317, 34000451, 34001345, 34000478, 34001378, 34000495, 34001389, 34000497, 34001390, 34000529, 34001396, 34000538, 34001422, 34000552, 34001472, 34000557, 34001504, 34000596, 34001569, 34000601, 34001572, 34000631, 34001589, 34000642, 34001610, 34000799, 34001633, 34000805, 34001668, 34000833, 34001809, 34000851, 34001840, 34000893, 34001850, 34000947, 34001897, 34001172, 34001218

Clinical Chemistry and Clinical Toxicology Devices

1

No

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

VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. || Intended for use in the measurement of a variety of chemistry analytes.

Serial Numbers: 1) J34000102 through J34002323, 2) 34000133, 34000193, 4000212, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557,  34000596, 34000601, 34000631, 34000642, 34000805, 34000833, 34000851, 34000893, 34000947, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001589, 34001610, 34001612, 34001633, 34001668, 34001809,  34001840, 34001850, 34001897, 3) J46000108 through J46000312, 4) J56000110 through J56001779.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA Nationwide in 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, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Puerto Rico and the countries of Mexico, Singapore, Venezuela, England, Germany, Italy & Spain.

Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 || Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.

Software Version 2.2.1, Serial Numbers 34000121 to 34001377.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and Worldwide

VITROS¿ 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS¿ Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375.