Device Recall VITROS 5,1 FS Chemistry System

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.)