DxI 9000 Access Immunoassay Analyzer
Medical device recall Z-1913-2025. Published in FDA’s Enforcement Report on Jun 11, 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 Jun 11, 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
- 231 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?
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
231 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 15099590732103; Serial Numbers: 300573 300572 300571 300570 300569 300568 300567 300566 300564 300563 300562 300561 300560 300559 300558 300557 300556 300555 300554 300553 300552 300551 300548 300547 300546 300544 300543 300542…
Every code shown here, 1,656 characters
UDI-DI: 15099590732103; Serial Numbers: 300573 300572 300571 300570 300569 300568 300567 300566 300564 300563 300562 300561 300560 300559 300558 300557 300556 300555 300554 300553 300552 300551 300548 300547 300546 300544 300543 300542 300541 300540 300539 300538 300537 300536 300535 300534 300533 300532 300531 300530 300528 300527 300526 300525 300524 300523 300522 300521 300520 300519 300518 300517 300516 300515 300514 300512 300511 300510 300509 300508 300507 300506 300501 300500 300497 300496 300495 300493 300491 300490 300489 300481 300479 300476 300475 300474 300470 300468 300467 300464 300458 300457 300455 300446 300438 300434 300430 300428 300427 300426 300425 300424 300423 300422 300420 300415 300414 300413 300411 300410 300409 300408 300407 300403 300398 300397 300396 300395 300393 300392 300389 300388 300378 300376 300375 300373 300372 300370 300362 300361 300360 300359 300358 300356 300354 300352 300350 300346 300341 300339 300338 300336 300334 300333 300331 300329 300328 300327 300326 300323 300322 300319 300318 300317 300316 300314 300312 300309 300306 300300 300299 300293 300288 300286 300285 300284 300283 300282 300280 300279 300275 300274 300273 300272 300270 300267 300266 300255 300252 300250 300249 300242 300240 300236 300235 300234 300232 300231 300228 300226 300225 300221 300219 300218 300217 300215 300214 300213 300212 300211 300210 300209 300208 300206 300205 300204 300201 300200 300198 300194 300193 300192 300191 300190 300186 300183 300182 300178 300175 300174 300171 300168 300166 300161 300158 300157 300156 300155 300154 300153 300150 300148 300145 300144 300138 300136 300132 300128 300126 300124 300116
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) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public of, Slovakia, Croatia, Cote d’lvoire, Australia, Ireland, Taiwan, Province of China, New Zealand, Austria, Hungary, Brazil, Israel, Portugal.
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 Apr 23, 2025.
- FDA classified it on Jun 5, 2025.
- FDA’s Enforcement Report published it on Jun 11, 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
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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.