CLASS II ONGOING Device recall · Reported 11 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-1913-2025
- FDA event ID
- 96762
- Recalling firm
- Beckman Coulter, Chaska, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Apr 2025
- FDA classified
- 5 Jun 2025
- Reported
- 11 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 | |
| 5 Jun 2025 | Classified by FDA | +43 days |
| 11 Jun 2025 | Published in enforcement report | +6 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 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.
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 version 1.20
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
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 26 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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