Beckman Coulter, Inc.: Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer

Hazard

An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.

Details from the source

Reason for recall: An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results. Distribution: Worldwide Quantity: 657 units Lot/code info: 973100, UDI/DI 15099590265373 (Chaska), Serial numbers: 610458, 610455, 610679, 610579, 610432, 610430, 610434, 610664, 610682, 610765, 610500, 610541, 610544, 610545, 610562, 610547, 610585, 610595, 610475, 610453, 610781, 610580, 610444, 610704, 610586, 610684, 610589, 610588, 610493, 610659, 610570, 610498, 610748, 610496, 610560, 610573, 610574, 610577, 610601, 610651, 610680, 610642, 610641, 610683, 610747, 610468, 610772, 610441, 610476, 610489, 610488, 610492, 610532, 610534, 610533, 610535, 610640, 610457, 610464, 610790, 610559, 610687, 610571, 610552, 610555, 610582, 610531, 610568, 610594, 610773, 610490, 610668, 610784, 610812, 610556, 610550, 610600, 610565, 610558, 610557, 610551, 610527, 610685, 610730, 610686, 610494, 610753, 610590, 610593, 610546, 610724, 610538, 610540, 610439, 610491, 610581, 610649, 610466, 610789, 610723, 610575, 610443, 610776, 610734, 610518, 610519, 610517, 610520, 610563, 610569, 610787, 610459, 610775, 610572, 610561, 610597, 610445, 610440, 610567, 610596, 610497, 610774, 610454, 610426, 610431, 610442, 610433, 610435, 610539, 610578, 610509, 610418, 610483, 610484, 610515, 610425, 610503, 610510, 610452, 610526, 610602, 610481, 610487, 610482, 610507, 610505, 610506, 610514, 610499, 610504, 610511, 610423, 610524, 610525, 610512, 610564, 610424, 610513, 610480, 610516, 610521, 610419, 610415, 610416, 610456, 610461, 610460, 610472, 610470, 610477, 610471, 610463, 610462, 610467, 610469, 610465, 610587, 610639, 610614, 610616, 6106

UPC codes

15099590265373, 16954701000412

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.