—#216447

Product

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

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K121790
Affected 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, 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.

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2025-10-01
Posted by FDA: 2025-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216447. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.