DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Device Recall #Z-2271-2025 — Class II — June 25, 2025
Recall Summary
| Recall Number | Z-2271-2025 |
| 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 | 177 systems |
Product Description
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
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: 15099590369224; Serial Numbers: 902515 902070 902390 902369 902429 902529 902598 902597 902275 902291 902339 902502 902278 902283 902329 902340 902528 902534 902392 902526 902527 902248 902249 902523 902522 902225 902524 902586 902427 902424 902505 902455 902413 902414 901697 902578 902579 902303 902264 902265 902428 902089 902227 902226 902228 902229 902256 902257 902075 902323 902197 902231 902270 902271 902301 902305 902273 902362 902342 901898 902545 902383 902530 902531 902416 901890 902581 902318 902316 902317 902454 902453 902451 902504 902514 902525 902535 902274 902102 902224 902356 902566 902223 902404 902307 902306 902083 902085 902328 902351 902350 902434 902433 902516 902518 902322 902391 902204 902415 902292 902294 902378 902379 902382 902334 902335 902532 902222 902365 902326 902327 902425 902293 902420 902419 902418 902246 902555 902558 902564 902588 902421 902432 902244 902245 902363 902364 902260 902290 902296 902519 902521 902559 902478 902456 902457 902549 902554 902435 902450 902253 902254 902582 902583 902352 902353 902357 902360 902361 902399 902547 902596 902252 902393 902398 902405 902426 902368 902412 902492 902281 902219 902220 902511 902610 902635 902625 902614 902615 902621 902620 902634 902609 902606 902601 902603 902604
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.