DxI 800 Access Immunoassay Analyzer W/Spot B
Medical device recall Z-2268-2025. 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
- 451 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 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
451 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 15099590369194; Serial Numbers: 609821 609831 609741 609746 608191 608200 608327 609460 609461 609468 609703 609762 608186 609046 609047 609095 609096 608992 608993 608999 608998 609766 609331 609358 609185 609182 609317 609760…
Every code shown here, 2,000 characters
UDI-DI: 15099590369194; Serial Numbers: 609821 609831 609741 609746 608191 608200 608327 609460 609461 609468 609703 609762 608186 609046 609047 609095 609096 608992 608993 608999 608998 609766 609331 609358 609185 609182 609317 609760 609081 609084 609125 609325 609213 609227 609161 609109 609111 609230 609316 609799 609451 609617 609698 609689 609813 608375 608355 609805 609804 608357 608366 609112 609124 609156 608259 609693 609694 609260 609553 609552 608367 609838 609515 609324 609330 609662 609767 609786 609078 609718 609719 608125 609181 609166 608211 609374 609359 608249 609007 606845 609757 609758 609065 609063 609549 609548 609237 609443 609394 608354 608356 609546 609733 609648 609653 609202 609201 609505 609734 608245 609738 609737 609234 609235 608148 608149 608153 608336 608376 609228 609229 609442 609514 609544 609545 609659 609656 609658 609655 609798 609817 609186 609128 609214 609162 609155 608187 609064 609066 609547 609550 609551 609652 609647 609657 609654 606065 606441 603736 608218 608250 609375 609386 609387 609393 609787 609679 609690 609489 609808 609837 609239 609261 605840 609036 609615 609614 609035 609129 609661 609660 609663 608132 609691 609697 609832 609449 609504 609110 609189 609190 609080 609079 609176 609236 609238 605066 609231 609232 608206 609446 609447 609448 609412 609311 609310 609811 609822 609488 609814 609816 609522 609523 609542 609749 609747 610231 610244 610166 610178 610185 610770 609968 610707 610844 610542 610448 610163 610167 610245 610700 610553 610566 610771 610834 610835 610252 610406 610713 610720 609980 609981 610079 610285 610286 610293 609864 610644 610648 610647 610691 610696 610162 610429 610428 610598 610915 610676 610712 610300 610184 610670 610721 610847 610848 610752 609902 609905 610015 610014 610157 610782 609906 609901 610128 610191 610192 610666 609971 609972 610632 610631 610796 610816 610901 609863 610258 610010 610001 610108 610066 610078 610135 610134 610051 610446 610903 609926 610095 610280…
FDA’s list runs to 3,196 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 3,196 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.