Beckman Coulter UniCel DxI 800 recall
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Why was Beckman Coulter UniCel DxI 800 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, 610608, 610605, 610645, 610634, 610623, 610626, 610615, 610633, 610622, 610609, 610621, 610672, 610678, 610674, 610671, 610667, 610673, 610675, 610677, 610650, 610662, 610692, 610646, 610693, 610652, 610661, 610663, 610654, 610655, 610689, 610653, 610656, 610657, 610694, 610688, 610658, 610660, 610725, 610729, 610732, 610731, 610719, 610726, 610703, 610709, 610718, 610715, 610717, 610716, 610698, 610702, 610714, 610711, 610705, 610706, 610697, 610710, 610755, 610757, 610754, 610756, 610767, 610766, 610769, 610768, 610785, 610788, 610800, 610793, 610794, 610795, 610801, 610814, 610811, 610758, 610786, 610744, 610804, 610736, 610737, 610742, 610750, 610802, 610806, 610791, 610759, 610762, 610738, 610739, 610740, 610741, 610792, 610805, 610808, 610733, 610761, 610763, 610798, 610803, 610735, 610810, 610760, 610749, 610799, 610809, 610764, 610745, 610743, 610746, 610829, 610832, 610833, 610830, 610831, 610827, 610828, 610825, 610826, 610822, 610807, 610813, 610821. UDI/DI 16954701000412 (Suzhou), Serial Numbers: 630104, 630105, 630160, 630159, 630162, 630110, 630140, 630175, 630143, 630103, 630108, 630174, 630099, 630112, 630113, 630136, 630107, 630102, 630100, 630106, 630115, 630114, 630132, 630111, 630101, 630109, 630146, 630139, 630116, 630126, 630117, 630118, 630120, 630119, 630121, 630122, 630123, 630124, 630125, 630129, 630128, 630130, 630131, 630134, 630135, 630137, 630141, 630142, 630133, 630127, 630164, 630172, 630173, 630144, 630156, 630145, 630157, 630158, 630155, 630154, 630149, 630152, 630170, 630171, 630150, 630151, 630153, 630163, 630148, 630147, 630138, 630194, 630197, 630202, 630203, 630178, 630184, 630166, 630186, 630182, 630176, 630205, 630179, 630180, 630181, 630195, 630187, 630161, 630169, 630167, 630165, 630193, 630191, 630192, 630190, 630177, 630188, 630183, 630196, 630199, 630168, 630219, 630208, 630217, 630230, 630223, 630214, 630210, 630235, 630232, 630201, 630226, 630227, 630218, 630233, 630221, 630222, 630216, 630215, 630206, 630207, 630211, 630231, 630209, 630224, 630234, 630228, 630220, 630225, 630229, 630204, 630212, 630213, 630259, 630260, 630252, 630281, 630282, 630272, 630265, 630279, 630256, 630255, 630269, 630242, 630248, 630241, 630264, 630275, 630270, 630249, 630253, 630271, 630267, 630278, 630254, 630263, 630243, 630246, 630273, 630280, 630238, 630251, 630257, 630258, 630274, 630240, 630244, 630247, 630262, 630237, 630266, 630236, 630261, 630245, 630307, 630300, 630301, 630315, 630284, 630319, 630327, 630296, 630292, 630304, 630305, 630311, 630310, 630312, 630324, 630291, 630321, 630323, 630325, 630289, 630316, 630317, 630308, 630306, 630318, 630299, 630314, 630302, 630313, 630290, 630285, 630298, 630293, 630295, 630303, 630320, 630309, 630294, 630287, 630286, 630331, 630288, 630322, 630328, 630337, 630351, 630341, 630345, 630344, 630343, 630342, 630340, 630334, 630330, 630332, 630336, 630338, 630333, 630339, 630347, 630346, 630348, 630326, 630198, 630189, 630276, 630353, 630185, 630352, 630329, 630277, 630283, 630297, 630349, 630200, 630239.
- Product
- Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 657 units
- Distribution
- Worldwide
- Recall date
- November 12, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)