CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report
UniCel DxI 600 Access Immunoassay Analyzer recalled by Beckman Coulter
Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay Analyzer, distributed nationwide in the US. The recall was initiated on 25 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2269-2025
- FDA event ID
- 97162
- Recalling firm
- Beckman Coulter, Chaska, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2025
- FDA classified
- 5 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Jun 2025 | Recall initiated by company | |
| 5 Aug 2025 | Classified by FDA | +41 days |
| 13 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97162This product is part of a recall event; the main page for the event is DxI 800 Access Immunoassay Analyzer W/Dual Gantry recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DxI 800 Access Immunoassay Analyzer W/Dual Gantry recalled | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | DxI 600 Access Immunoassay Analyzer W/Spot recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | DxI 800 Access Immunoassay Analyzer W/Spot recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | DxI 600 Access Immunoassay Analyzer W/Dual Gantry recalled | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | UniCel DxI 800 Access Immunoassay Analyzer recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide |
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