Class 2 Device Recall Beckman Coulter UniCel DXI 800

• Date Initiated by Firm: October 01, 2025
• Date Posted: November 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0429-2026
• Recall Event ID: 97730
• 510(K)Number: K121790
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
• Code Information: 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.
• FEI Number: 2122870
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 1000 Lake Hazeltine Dr; Chaska MN 55318-1037
• For Additional Information Contact: Ian Pilcher; 952-448-4848
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: Beckman Coulter issue an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/01/2025 via USPS and email. The notice explained the issue, potential impact, and requested the following: If Wash PnP and/or Incubator PnP Z-motion errors appear in the analyzer event log, take the following steps: 1. Attempt to reinitialize the analyzer: a. Go to the Diagnostics screen on the User Interface. b. Select Initialize System. 2. If reinitialization is unsuccessful, contact Beckman Coulter Technical Support in your region. Beckman Coulter recommends posting this letter on or near the affected analyzers. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter. A field service representative will contact your laboratory to schedule a time to replace the affected parts. If you have any questions regarding this notice, please contact our Customer Support Center website: http://www.beckmancoulter.com
• Quantity in Commerce: 657 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JJE