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U.S. Department of Health and Human Services

Class 2 Device Recall DxI 9000 Access Immunoassay Analyzer

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 Class 2 Device Recall DxI 9000 Access Immunoassay Analyzersee related information
Date Initiated by FirmSeptember 19, 2025
Date PostedOctober 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0216-2026
Recall Event ID 97638
510(K)NumberK221225 
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
ProductDxI 9000 Access Immunoassay Analyzer, Part Number C11137
Code Information C11137 UDI-DI: 15099590732103; Serial Numbers: 300621 300655 300564 300572 300411 300425 300576 300577 300625 300295 300713 300714 300289 300497 300333 300520 300524 300440 300443 300441 300444 300445 300528 300515 300332 300466 300484 300412 300395 300541 300255 300270 300499 300435 300436 300467 300532 300560 300600 300604 300605 300607 300609 300610 300707 300709 300710 300596 300597 300374 300679 300677 300558 300559 300593 300584 300169 300239 300124 300225 300595 300638 300495 300496 300381 300668 300237 300156 300571 300641 300131 300637 300488 300142 300141 300143 300151 300152 300316 300546 300298 300299 300328 300414 300413 300422 300132 300534 300317 300318 300567 300568 300163 300162 300276 300277 300174 300226 300370 300459 300386 300503 300388 300389 300745 300742 300204 300216 300247 300246 300438 300149 300662 300716 300268 300380 300391 300429 300437 300303 300305 300349 300353 300290 300301 300243 300220 300166 300176 300188 300269 300273 300144 300398 300229 300721 300722 300199 300200 300309 300632 300602 300601 300314 300177 300224 300669 300628 300291 300223 300456 300719 300718 300410 300547 300450 300649 300116 300171 300368 300145 300250 300288 300331 300338 300362 300407 300670 300693 300190 300230 300235 300297 300203 300465 300241 300280 300684 300686 300493 300324 300570 300569 300592 300657 300285 300358 300457 300460 300249 300533 300680 300681 300682 300462 300373 300729 300665 300148 300153 300154 300158 300178 300267 300591 300616 300406 300405 300672 300354 300385 300504 300505 300433 300432 300136 300711 300712 300501 300506 300117 300312 300195 300516 300402 300189 300514 300279 300126 300401 300537 300403 300464 300683 300664 300198 300491 300490 300420 300424 300327 300423 300427 300426 300579 300687 300688 300689 300699 300308 300307 300227 300228 300431 300430 300371 300238 300155 300329 300168 300245 300727 300726 300651 300194 300614 300613 300343 300240 300557 300483 300676 300675 300643 300674 300205 300207 300206 300315 300356 300409 300408 300691 300692 300283 300256 300135 300197 300626 300218 300306 300399 300179 300182 300123 300147 300523 300522 300563 300566 300598 300599 300561 300562 300500 300512 300530 300531 300548 300606 300573 300545 300574 300585 300733 300448 300449 300400 300404 300447 300627 300624 300630 300477 300473 300653 300701 300700 300161 300258 300697 300708 300478 300471 300581 300582 300603 300617 300611 300615 300622 300635 300192 300234 300489 300544 300658 300377 300453 300417 300421 300461 300469 300472 300527 300372 300470 300647 300272 300150 300479 300539 300219 300507 300508 300310 300482 300193 300535 300341 300475 300474 300351 300685 300724 300725 300183 300723 300646 300293 300551 300518 300259 300340 300639 300352 300355 300359 300620 300636 300652 300284 300286 300397 300129 300130 300133 300134 300695 300254 300261 300264 300263 300325 300553 300379 300587 300667 300540 300556 300208 300342 300345 300347 300580 300583 300734 300736 300619 300618 300575 300578 300434 300164 300167 300201 300232 300281 300282 300322 300323 300330 300175 300376 300378 300326 300594 300590 300253 300302 300172 300468 300476 300393 300392 300732 300731 300717 300715 300287 300416 300510 300631 300629 300743 300552 300294 300337 300660 300661 300300 300633 300640 300735 300209 300212 300211 300213 300214 300215 300525 300526 300648 300650 300554 300555 300517 300369 300160 300480 300454 300519 300509 300543 300455 300458 300387 300137 300139 300498 300702 300586 300210 300339 300346 300350 300741 300740 300705 300706 300728 300361 300360 300451 300452 300536 300673 300671 300296 300538 300248 300304 300511 300275 300366 300367 300446 300128 300217 300485 300170 300334 300415 300271 300313 300266 300231 300666 300196 300494 300703 300704 300481 300502 300542 300222 300138 300396 300173 300320 300612 300439 300442 300738 300549 300274 300181 300202 300236 300242 300428 300191 300233 300252 300644 300656 300336 300186 300382 300659 300696 300694 300375 300634 300698 300157 300521 300623 300645 300321 300654
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 confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
FDA Determined
Cause 2		Software design
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 9/12/25 was sent to customers. " When ordering tests for a manually diluted sample through the Test Order Entry page, a unique sample ID is required. " Alternatively, use the Dilute and Rerun feature or an automated dilution to measure diluted samples. Refer to Rerunning a Test with a Diluted Sample in the System Help for more information. " Beckman Coulter suggests sharing this letter with your Medical Director to determine if performing a retrospective review of results is necessary. " Beckman Coulter is investigating the root cause of this issue and will implement a correction with a future software release. " Your Beckman Coulter service representative will contact you to schedule the software upgrade 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 Customer Support Center: " From our website: http://www.beckmancoulter.com
Quantity in Commerce571 units
DistributionWorldwide - US Nationwide distribution.
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 = JLW
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