DxI 9000 Access Immunoassay Analyzer
Medical device recall Z-0216-2026. Published in FDA’s Enforcement Report on Oct 29, 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 Oct 29, 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
- 571 units 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 confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already “In Progress” using the same “Sample ID number”. This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
571 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
C11137 UDI-DI: 15099590732103; Serial Numbers: 300621 300655 300564 300572 300411 300425 300576 300577 300625 300295 300713 300714 300289 300497 300333 300520 300524 300440 300443 300441 300444 300445 300528 300515 300332 300466 300484…
Every code shown here, 2,000 characters
C11137 UDI-DI: 15099590732103; Serial Numbers: 300621 300655 300564 300572 300411 300425 300576 300577 300625 300295 300713 300714 300289 300497 300333 300520 300524 300440 300443 300441 300444 300445 300528 300515 300332 300466 300484 300412 300395 300541 300255 300270 300499 300435 300436 300467 300532 300560 300600 300604 300605 300607 300609 300610 300707 300709 300710 300596 300597 300374 300679 300677 300558 300559 300593 300584 300169 300239 300124 300225 300595 300638 300495 300496 300381 300668 300237 300156 300571 300641 300131 300637 300488 300142 300141 300143 300151 300152 300316 300546 300298 300299 300328 300414 300413 300422 300132 300534 300317 300318 300567 300568 300163 300162 300276 300277 300174 300226 300370 300459 300386 300503 300388 300389 300745 300742 300204 300216 300247 300246 300438 300149 300662 300716 300268 300380 300391 300429 300437 300303 300305 300349 300353 300290 300301 300243 300220 300166 300176 300188 300269 300273 300144 300398 300229 300721 300722 300199 300200 300309 300632 300602 300601 300314 300177 300224 300669 300628 300291 300223 300456 300719 300718 300410 300547 300450 300649 300116 300171 300368 300145 300250 300288 300331 300338 300362 300407 300670 300693 300190 300230 300235 300297 300203 300465 300241 300280 300684 300686 300493 300324 300570 300569 300592 300657 300285 300358 300457 300460 300249 300533 300680 300681 300682 300462 300373 300729 300665 300148 300153 300154 300158 300178 300267 300591 300616 300406 300405 300672 300354 300385 300504 300505 300433 300432 300136 300711 300712 300501 300506 300117 300312 300195 300516 300402 300189 300514 300279 300126 300401 300537 300403 300464 300683 300664 300198 300491 300490 300420 300424 300327 300423 300427 300426 300579 300687 300688 300689 300699 300308 300307 300227 300228 300431 300430 300371 300238 300155 300329 300168 300245 300727 300726 300651 300194 300614 300613 300343 300240 300557 300483 300676 300675 300643 300674 300205 300207 300206 300315…
FDA’s list runs to 4,043 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 - US Nationwide distribution.
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 Sep 19, 2025.
- FDA classified it on Oct 21, 2025.
- FDA’s Enforcement Report published it on Oct 29, 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 4,043 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
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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.