FDA Device recall Z-2269-2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260 by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2269-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-25 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Reason
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.
Identifiers
| code_info | UDI-DI: 15099590341602; Serial Numbers: 902467 902468 902465 902464 902466 902469 902476 902477 902479 902480 902481 90…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 9 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2269-2025%22
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