UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Device Recall #Z-2269-2025 — Class II — June 25, 2025
Recall Summary
| Recall Number | Z-2269-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 25, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beckman Coulter, Inc. |
| Location | Chaska, MN |
| Product Type | Devices |
| Quantity | 271 systems |
Product Description
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
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.
Distribution Pattern
Worldwide distribution - US Nationwide.
Lot / 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
Other Recalls from Beckman Coulter, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1922-2026 | Class II | Access Total T4 Calibrator, Catalog No. 33805 | Mar 16, 2026 |
| Z-1235-2026 | Class II | CellMek SPS Sample Preparation System, REF: C44... | Dec 23, 2025 |
| Z-1025-2026 | Class II | Beckman Coulter UniCel Dxl 600, Part numbers: ... | Nov 26, 2025 |
| Z-1026-2026 | Class II | Beckman Coulter UniCel Dxl 800, Part numbers: ... | Nov 26, 2025 |
| Z-1221-2026 | Class II | COULTER DxH Diluent, REF 628017 COULTER DxH EC... | Nov 10, 2025 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.