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RecallWatchMedical Device Safety
Class IIOngoingZ-2266-2025

Beckman Coulter, Inc. recalls UniCel DxI 800 Access Immunoassay Analyzer

Beckman Coulter, Inc.Chaska, MN, United StatesReported Aug 13, 2025 · 11 months ago
Legal News Analyst ·

Reason for recall

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100

Lot / code information

UDI
15099590265373
Serial #
608114 608209 609132 609163 608344 608113 608233 609224 609218 609221 609070 609071 609117 608164 609591 609692 608197 609534 609455 609524 609319 609062 609094 609452 609750 609801 609686 609198 6096…Show all
608114 608209 609132 609163 608344 608113 608233 609224 609218 609221 609070 609071 609117 608164 609591 609692 608197 609534 609455 609524 609319 609062 609094 609452 609750 609801 609686 609198 609644 609518 609745 609496 608387 609183 609188 609699 609735 609618 609492 609028 609583 609765 609790 609187 605528 609137 609157 609226 608242 608243 609191 609527 609256 608996 609003 609327 609262 609264 609294 609321 609329 609265 609290 609397 609521 609320 608106 609373 608386 608389 609372 609846 609153 609241 609498 609519 609520 609744 609704 609491 609802 609810 609807 609806 608234 609286 609739 609824 609270 609103 609643 609641 609123 609192 609093 609499 609497 609429 609410 608994 609122 608247 609334 607653 609849 609100 609101 609370 608391 608362 609371 609136 609195 608264 608265 607196 609784 609494 609223 609526 609220 608347 609197 609099 609098 609097 609576 609285 609225 609626 609640 609150 609233 609803 609283 609322 609537 609318 609827 609462 609180 609408 609244 609754 609795 609791 609797 609800 609789 609532 609531 609538 609539 609543 609541 609599 609338 608256 609323 609536 608346 609833 606661 608388 609001 609246 608393 609369 609535 609031 609092 609582 609834 604083 609740 609513 609210 609378 608188 609017 609018 609005 608172 609030 609385 609649 609053 609263 609184 608176 608238 609209 609020 608385 608384 608382 608276 608202 608997 609023 608205 609004 609102 609016 608175 609015 608171 609019 608246 609002 608379 608235 608381 608170 609051 609193 609196 609194 609135 609151 609050 609014 609203 608165 608225 608983 609069 609068 608093 608136 608984 609011 608231 608227 609083 609215 609108 608365 608110 609272 609025 609024 609033 608990 608098 608223 609284 609255 607108 608267 609143 608217 608190 609276 608988 608987 608169 609054 608221 608133 608135 609277 608210 608383 608995 608986 608121 608241 608184 608204 609104 609106 608157 609280 608350 609251 608219 608159 608168 608122 609059 608139 608162 608372 608193 609037 608364 608369 609009 609057 609086 609058 609075 608230 609271 608253 608252 609038 608257 608262 608220 608104 609072 609089 609091 609090 609140 609074 608237 608240 608163 608166 608359 609133 609275 609274 608096 608173 609273 609222 608116 609249 609174 608261 608260 608251 609269 609067 609021 608991 609012 609144 608208 609240 609105 609115 609029 609034 609288 609248 608124 608394 609164 609247 609032 609154 608161 609152 608099 608196 609179 609258 609257 609268 609266 608185 608138 609206 608192 608101 608152 609172 608103 609073 609204 609211 608179 609175 608352 609049 609168 608117 609199 608154 608156 608155 608232 608236 609041 609042 608201 608203 609245 609126 609131 608351 609149 609043 609252 609158 608183 609027 609208 608160 609076 608174 608158 608269 608268 608150 609052 609056 609060 609061 608199 608212 608180 608102 608189 608248 609282 609281 609145 608120 608373 608377 609170 608119 608274 609141 609267 608380 609159 609219 609114 609142 608254 608118 609000 608272 609044 609242 609165 608100 608239 609087 609082 609171 608229 608982 608123 608244 609200 608115 608134 609278 608137 608095 608226 608358 609107 609077 609088 609130 608255 608349 608258 609010 608371 609253 609205 608215 608213 608214 608216 609127 608089 609254 609259 608090 609139 609148 609146 609040 609169 608275 609207 608222 608131 608151 609113 609212 609243 608108 609085 608097 609167 608195 608263 608271 609118 608989 609045 608105 609454 609459 609453 609487 609398 609416 609585 609588 609645 609742 609788 609793 609792 609419 609646 609841 609368 609495 609528 609433 609530 609493 609529 609736 609340 609362 609361 609403 609406 609840 609575 609407 609830 609850 609440 609589 609577 609590 609595 609705 609845 609716 609721 609420 609701 609405 609634 609345 609728 609759 609562 609720 609508 609625 609763 609353 609619 609470 609540 609775 609796 609415 609753 609709 609598 609472 609722 609779 609783 609342 609348 609346 609395 609633 609314 609292 609293 609642 609347 609439 609771 609404 609776 609388 609384 609609 609761 609304 609337 609777 609780 609717 609611 609306 609307 609309 609332 609715 609507 609533 609688 609695 609606 609579 609578 609391 609710 609712 609352 609458 609456 609296 609302 609335 609349 609592 609755 609413 609559 609764 609563 609424 609572 609593 609843 609554 609477 609603 609602 609622 609651 609835 609564 609511 609823 609772 609781 609785 609289 609300 609584 609596 609431 609706 609555 609669 609668 609664 609360 609474 609638 609723 609724 609568 609401 609441 609639 609631 609426 609481 609483 609437 609435 609434 609467 609445 609673 609392 609773 609819 609305 609418 609428 609610 609376 609390 609363 609678 609417 609512 609287 609600 609607 609608 609613 609382 609381 609478 609557 609580 609828 609383 609560 609605 609685 609683 609682 609684 609510 609409 609351 609558 609357 609601 609315 609400 609713 609475 609463 609295 609303 609842 609377 609379 609465 609708 609473 609411 609438 609681 609680 609367 609604 609422 609469 609500 609730 609425 609502 609501 609503 609476 609677 609621 609674 609597 609350 609341 609308 609301 609711 609471 609571 609570 609573 609725 609343 609444 609825 609354 609687 609479 609556 609628 609632 609769 609525 609399 609629 609402 609366 609727 609726 609297 609670 609671 609672 609612 609299 609344 609627 609484 609333 609635 609389 609729 609637 609414 609291 609774 609423 609490 609485 609486 609565 609620 609839 609847 609623 609616 609848 609364 609820 609365 609818 609482 609506 609665 609509 609778 609770 609567 609566 609432 609430 609731 609732 609587 609782 609826 609829 609714 609312 609313 609561 609624 609356 609436 609569 609421 609768 609298 609380 609464 609427 609217 609339 609594 609160 609026 610312 610315 610314 610313 610350 610353 610352 610351 610354 610458 610455 610679 610579 610047 610224 610227 610265 610263 610264 610276 610266 610269 610270 610275 610274 610279 610295 610331 610330 610332 610333 610339 610337 6 …

What the firm is doing

An URGENT MEDICAL DEVICE RECALL notification dated 6/25/25 was sent to customers. ACTION: If your laboratory encounters any of the events described in this letter: " Perform a system initialization to resume normal operation. o If repeated initialization attempts fail, contact Customer Technical Support. " Repeat testing for any cancelled tests. " No action is required if your laboratory has not observed the events listed above ESOLUTION: "A Beckman Coulter representative will schedule the modification installation when it is available. 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 product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support: " From our website: http://www.beckmancoulter.com

DistributionShow details

Worldwide distribution - US Nationwide.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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