VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 107587500...
FDA Recall #Z-1075-2016 — Class II — December 21, 2015
Product Description
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.)
Reason for Recall
Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).
Recalling Firm
Ortho-Clinical Diagnostics — Rochester, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
US = 994; Foreign = 1405
Distribution
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
Code Information
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated