CLASS II ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report

DxI 9000 Access Immunoassay Analyzer C11137 recalled by Beckman Coulter

Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzer C11137, distributed nationwide in the US. The recall was initiated on 7 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 15099590732103 Serial Numbers 300116 300124 300126 300128 300132 300136 300138 300144 300145 300148 300150 300153 300154 300155 300156 300157 300158 300161 300166 300168 300171 300174 300175 300178 300179 300182 300183 300186 300190 300191 300192 300193 300194 300198 300200 300201 300204 300205 300206 300207 300208 300209 300210 300211 300212 300213 300214 300215 300217 300218 300219 300221 300225 300226 300228 300231 300232 300234 300235 300236 300240 300242 300246 300249 300250 300252 300255 300266 300267 300270 300272 300273 300274 300275 300279 300280 300282 300283 300284 300285 300286 300288 300293 300299 300300 300306 300307 300308 300309 300312 300314 300316 300317 300318 300319 300321 300322 300323 300326 300327 300328 300329 300331 300333 300334 300336 300338 300339 300341 300346 300350 300352 300354 300355 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 300454 300455 300457 300458 300461 300464 300467 300468 300470 300474 300475 300476 300479 300481 300483 300489 300490 300491 300493 300495 300496 300497 300500 300501 300506 300507 300508 300509 300510 300511 300512 300514 300515 300516 300517 300518 300519 300521 300522 300523 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 300565 300566 300567 300568 300569 300570 300571 300572 300573 300574 300575 300576 300577 300578 300579

Quantity recalled67 US; 178 OUS

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-1996-2025
FDA event ID: 96876
Recalling firm: Beckman Coulter, Chaska, MN
Classification: Class II
Status: Ongoing
Recall initiated: 7 May 2025
FDA classified: 20 Jun 2025
Reported: 2 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

7 May 2025	Recall initiated by company
20 Jun 2025	Classified by FDA	+44 days
2 Jul 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

Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

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 C11137

Where it was distributed

Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI, ID, IL, IN, KY, LA, ME, MI, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, WA, WI and the countries of Algeria, Australia, Austria, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, France, Germany, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Libya, New Zealand, Oman, Poland, Portugal, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom of Great Britain and Northern Ireland.

Nationwide Arkansas California Florida Georgia Hawaii Idaho Illinois Indiana Kentucky Louisiana Maine Michigan New Hampshire New Jersey New York Ohio Oklahoma Oregon Pennsylvania South Dakota

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 15099590732103 Serial Numbers 300116 300124 300126 300128 300132 300136 300138 300144 300145 300148 300150 300153 300154 300155 300156 300157 300158 300161 300166 300168 300171 300174 300175 300178 300179 300182 300183 300186 300190 300191 300192 300193 300194 300198 300200 300201 300204 300205 300206 300207 300208 300209 300210 300211 300212 300213 300214 300215 300217 300218 300219 300221 300225 300226 300228 300231 300232 300234 300235 300236 300240 300242 300246 300249 300250 300252 300255 300266 300267 300270 300272 300273 300274 300275 300279 300280 300282 300283 300284 300285 300286 300288 300293 300299 300300 300306 300307 300308 300309 300312 300314 300316 300317 300318 300319 300321 300322 300323 300326 300327 300328 300329 300331 300333 300334 300336 300338 300339 300341 300346 300350 300352 300354 300355 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 300454 300455 300457 300458 300461 300464 300467 300468 300470 300474 300475 300476 300479 300481 300483 300489 300490 300491 300493 300495 300496 300497 300500 300501 300506 300507 300508 300509 300510 300511 300512 300514 300515 300516 300517 300518 300519 300521 300522 300523 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 300565 300566 300567 300568 300569 300570 300571 300572 300573 300574 300575 300576 300577 300578 300579

Where was it sold?

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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