UniCel DxI 600 Access Immunoassay Analyzer
Medical device recall Z-2269-2025. Published in FDA’s Enforcement Report on Aug 13, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 13, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 271 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
271 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,936 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 25, 2025.
- FDA classified it on Aug 5, 2025.
- FDA’s Enforcement Report published it on Aug 13, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter, Inc., of Chaska, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.