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U.S. Department of Health and Human Services

Class 2 Device Recall DxI 800 Access Immunoassay Analyzer W/Spot B

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 Class 2 Device Recall DxI 800 Access Immunoassay Analyzer W/Spot Bsee related information
Date Initiated by FirmJune 25, 2025
Date PostedAugust 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2268-2025
Recall Event ID 97162
510(K)NumberK023764 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductDxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Code Information UDI-DI: 15099590369194; Serial Numbers: 609821 609831 609741 609746 608191 608200 608327 609460 609461 609468 609703 609762 608186 609046 609047 609095 609096 608992 608993 608999 608998 609766 609331 609358 609185 609182 609317 609760 609081 609084 609125 609325 609213 609227 609161 609109 609111 609230 609316 609799 609451 609617 609698 609689 609813 608375 608355 609805 609804 608357 608366 609112 609124 609156 608259 609693 609694 609260 609553 609552 608367 609838 609515 609324 609330 609662 609767 609786 609078 609718 609719 608125 609181 609166 608211 609374 609359 608249 609007 606845 609757 609758 609065 609063 609549 609548 609237 609443 609394 608354 608356 609546 609733 609648 609653 609202 609201 609505 609734 608245 609738 609737 609234 609235 608148 608149 608153 608336 608376 609228 609229 609442 609514 609544 609545 609659 609656 609658 609655 609798 609817 609186 609128 609214 609162 609155 608187 609064 609066 609547 609550 609551 609652 609647 609657 609654 606065 606441 603736 608218 608250 609375 609386 609387 609393 609787 609679 609690 609489 609808 609837 609239 609261 605840 609036 609615 609614 609035 609129 609661 609660 609663 608132 609691 609697 609832 609449 609504 609110 609189 609190 609080 609079 609176 609236 609238 605066 609231 609232 608206 609446 609447 609448 609412 609311 609310 609811 609822 609488 609814 609816 609522 609523 609542 609749 609747 610231 610244 610166 610178 610185 610770 609968 610707 610844 610542 610448 610163 610167 610245 610700 610553 610566 610771 610834 610835 610252 610406 610713 610720 609980 609981 610079 610285 610286 610293 609864 610644 610648 610647 610691 610696 610162 610429 610428 610598 610915 610676 610712 610300 610184 610670 610721 610847 610848 610752 609902 609905 610015 610014 610157 610782 609906 609901 610128 610191 610192 610666 609971 609972 610632 610631 610796 610816 610901 609863 610258 610010 610001 610108 610066 610078 610135 610134 610051 610446 610903 609926 610095 610280 610281 610536 610065 610611 610610 610607 610217 610222 610478 610479 610584 610291 610292 610783 610450 610412 610329 610050 610413 610172 610171 610722 610407 610815 610817 610779 610780 609927 609948 609947 610249 609857 609856 609969 610027 610040 610034 610102 610103 610094 610141 610142 610145 610225 610226 610229 610230 610234 610236 610238 610235 610239 610335 610334 610620 610625 610627 610624 610635 610636 610643 610665 610695 610699 610708 610777 610778 610819 610818 610820 610205 610221 610272 610277 610290 610304 610523 610528 610000 610204 610232 610233 610495 610508 610522 610619 610728 610727 610751 610637 610420 610530 610529 610857 610149 610449 610127 610299 610427 610473 610248 610303 610629 610177 610638 610669 610146 610148 610628 610630 610486 610485 610612 610690 610548 610549 610599 610606 610604 610603 610591 610592 610858 610824 610218 610158 610823 609962 610041 610049 610554 610328 609956 609957 610856 610259 610268 610267 610474 610436 610437 610107 610845 611007 610998 610999 610997 610996 610924 610925 610947 610951 610948 610969 610968 610970 610950 610973 610972 610982 610949 610986 610988 611008 610987 610971 610952 610995 610967 610930 610966
FEI Number 2122870
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information ContactIan Pilcher
952-448-4848
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionAn 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
Quantity in Commerce451 systems
DistributionWorldwide distribution - US Nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJE
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