DxI 600 Access Immunoassay Analyzer W/Spot B
Medical device recall Z-2271-2025. 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
- 177 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?
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
177 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,278 characters
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
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.