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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel DxI 600 Access Immunoassay Analyzer

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 Class 2 Device Recall UniCel DxI 600 Access Immunoassay Analyzersee related information
Date Initiated by FirmJune 25, 2025
Date PostedAugust 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2269-2025
Recall Event ID 97162
510(K)NumberK023764 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductUniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Code Information UDI-DI: 15099590341602; Serial Numbers: 902467 902468 902465 902464 902466 902469 902476 902477 902479 902480 902481 902482 902483 902485 902484 902486 902487 902489 902313 902310 902384 902536 902347 902584 902355 902394 902541 902054 902058 902324 902090 902403 902417 902471 902517 902563 902080 902565 902320 902308 902388 902440 902330 902337 902503 902557 902279 902287 902269 902513 902507 902543 902449 902494 902300 902286 902250 902259 902562 902506 902508 902311 902560 902207 902587 902345 902574 902208 902211 902243 902262 902263 902295 902533 902572 902470 902319 902336 902251 901723 902344 902195 902282 902280 902448 902458 902381 902406 902372 902198 902540 902199 902234 902209 902217 902276 902569 902568 902577 902510 902078 902438 902056 902203 902205 902593 902439 902380 902397 902309 902196 902410 902402 902367 902585 902241 902423 902343 902595 902206 902210 902338 902202 902442 902445 902074 902076 902359 902288 902073 902072 902400 902580 902389 902567 902573 902461 902396 902570 902571 902221 902538 902411 902473 902495 902496 902200 902201 902472 902349 902084 902258 902341 902497 902553 902552 902299 902499 902512 902498 902215 902267 902266 902255 902214 902375 902539 902590 902589 902304 902422 902082 902235 902561 902100 902272 902474 902575 902446 902544 902354 902358 902059 902232 902240 902441 902490 902298 902542 902297 902371 902370 902321 902284 902373 902237 902079 902285 902556 902408 902374 902387 902230 902242 902238 902591 902462 902463 902537 902348 902493 902091 902509 902268 902460 902385 902386 902216 902447 902377 902376 902501 902475 902312 902315 902520 902500 902289 902395 902443 902325 902366 902444 902332 902333 902401 902491 902546 902548 902592 902218 902233 902551 902071 902550 902576 902346 902452 902602 902605 902633 902632 902611 902616 902630 902629 902599 902622 902624 902623 902631 902628 902600 902626 902627 902613 902617 902618 902619 902608 902607
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 Commerce271 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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