Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

Recall number

Z-1387-2025

Recalling firm

Beckman Coulter, Inc.

Product

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

Status

Open, Classified

Initiated

2025-02-06

Posted

2025-03-17

Terminated

not on file

Reason

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.

Root cause

Device Design

Action

An URGENT MEDICAL DEVICE RECALL notification letter was sent to customers beginning on 2/6/25. Beckman Coulter has determined that a DxI 9000 Access Immunoassay Analyzer containing tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. If the analyzer experiences the issue described above, it can lead to the analyzer entering the red, or Stopped, system status due to Reagent Storage and Tip Stocker "axis is out of tolerance" errors. Any in process tests that require addition of reagent at the time of the error are cancelled. There could be a delay in reporting patient test results to the physician. If the error occurs: 1. Confirm that the DxI 9000 Access Immunoassay Analyzer is in either the Paused or Stopped system state. 2. Select the System state button in the lower left corner of the user interface. 3. Select Initialize. When initialization is complete, the analyzer returns to the green, or Running, state. If your laboratory has experienced the issue and it is not resolved by initializing the analyzer, contact your Beckman Coulter representative and schedule a service visit. Beckman Coulter has identified the root cause of this issue and is no longer distributing affected TSI-RSI boards. A Beckman Coulter service representative will schedule a visit to replace any affected TSI-RSI boards on your DxI 9000 Access Immunoassay Analyzer. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email. Manually, complete and return the enclosed Response Form. I

Quantity

80 units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K221225"]

PMA numbers

not on file

Product code

JJE

Firm FEI

2122870

Firm city

Chaska

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy