CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
DxI 9000 Access Immunoassay Analyzer recalled by Beckman Coulter
Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzer, distributed nationwide in the US. The recall was initiated on 23 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1926-2025
- FDA event ID
- 96760
- Recalling firm
- Beckman Coulter, Chaska, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Apr 2025
- FDA classified
- 6 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Apr 2025 | Recall initiated by company | |
| 6 Jun 2025 | Classified by FDA | +44 days |
| 18 Jun 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation 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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Where it was distributed
Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of China, India, United Kingdom of Great Britain and Northern Ireland, Hungary, Austria, Portugal, Croatia, Kazakhstan, Cote d'lvoire, Poland, Korea, Republic of, Czechia, Algeria, Libya, Oman, Singapore, and Belgium.
Questions about this recall
Is DxI 9000 Access Immunoassay Analyzer recalled?
Yes. Beckman Coulter recalled DxI 9000 Access Immunoassay Analyzer on 23 Apr 2025. The recall is Class II and its status is Ongoing. Recall number Z-1926-2025.
Why was it recalled?
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation 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.
Which lots are affected?
UDI-DI: 15099590732103; Serial Numbers: 300144 300145 300148 300150 300153 300154 300155 300156 300157 300158 300161 300166 300168 300171 300174 300175 300178 300182 300183 300186 300190 300191 300192 300193 300194 300198 300200 300201 300204 300205 300206 300208 300209 300210 300211 300212 300213 300214 300215 300217 300218 300219 300221 300225 300226 300228 300231 300232 300234 300235 300236 300240 300242 300249 300250 300252 300255 300266 300267 300270 300272 300273 300274 300275 300279 300280 300282 300283 300284 300285 300286 300288 300293 300299 300300 300306 300309 300312 300314 300316 300317 300318 300319 300322 300323 300326 300327 300328 300329 300331 300333 300334 300336 300338 300339 300341 300346 300350 300352 300354 300356 300358 300359 300360 300361 300362 300370 300372 300373 300375 300376 300378 300388 300389 300392 300393 300395 300396 300397 300398 300403 300407 300408 300409 300410 300411 300413 300414 300415 300420 300422 300423 300424 300425 300426 300427 300428 300430 300434 300438 300446 300455 300457 300458 300464 300467 300468 300470 300474 300475 300476 300479 300481 300489 300490 300491 300493 300495 300496 300497 300500 300501 300506 300507 300508 300509 300510 300511 300512 300514 300515 300516 300517 300518 300519 300520 300521 300522 300523 300524 300525 300526 300527 300528 300530 300531 300532 300533 300534 300535 300536 300537 300538 300539 300540 300541 300542 300543 300544 300546 300547 300548 300551 300552 300553 300554 300555 300556 300557 300558 300559 300560 300561 300562 300563 300564 300566 300567 300568 300569 300570 300571 300572 300573
Where was it sold?
Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of China, India, United Kingdom of Great Britain and Northern Ireland, Hungary, Austria, Portugal, Croatia, Kazakhstan, Cote d'lvoire, Poland, Korea, Republic of, Czechia, Algeria, Libya, Oman, Singapore, and Belgium.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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