CLASS II ONGOING Device recall · Reported 26 Mar 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 6 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 15099590732103; Serial Numbers: 300158 300161 300164 300167 300169 300175 300178 300179 300182 300183 300185 300189 300194 300197 300201 300202 300204 300210 300216 300217 300218 300220 300224 300225 300233 300234 300236 300237 300239 300240 300241 300243 300244 300246 300247 300252 300255 300256 300260 300267 300270 300272 300273 300275 300280 300288 300290 300295 300296 300299 300300 300304 300313 300314 300317 300318 300321 300322 300323 300324 300333 300334 300336 300338 300339 300341 300351 300362 300364 300368 300370 300373 300374 300375 300379 300380 300385 300386 300388 300389

Quantity recalled80 units

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-1387-2025
FDA event ID: 96268
Recalling firm: Beckman Coulter, Chaska, MN
Classification: Class II
Status: Ongoing
Recall initiated: 6 Feb 2025
FDA classified: 17 Mar 2025
Reported: 26 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

6 Feb 2025	Recall initiated by company
17 Mar 2025	Classified by FDA	+39 days
26 Mar 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

Where it was distributed

Worldwide - US Nationwide distribution in the states of FL, TX, WA.

Nationwide Florida Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 15099590732103; Serial Numbers: 300158 300161 300164 300167 300169 300175 300178 300179 300182 300183 300185 300189 300194 300197 300201 300202 300204 300210 300216 300217 300218 300220 300224 300225 300233 300234 300236 300237 300239 300240 300241 300243 300244 300246 300247 300252 300255 300256 300260 300267 300270 300272 300273 300275 300280 300288 300290 300295 300296 300299 300300 300304 300313 300314 300317 300318 300321 300322 300323 300324 300333 300334 300336 300338 300339 300341 300351 300362 300364 300368 300370 300373 300374 300375 300379 300380 300385 300386 300388 300389

Where was it sold?

Worldwide - US Nationwide distribution in the states of FL, TX, WA.

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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