FDA Device recall Z-1926-2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20 by Beckman Coulter, citing A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1926-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-23 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Reason
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.
Identifiers
| code_info | UDI-DI: 15099590732103; Serial Numbers: 300144 300145 300148 300150 300153 300154 300155 300156 300157 300158 300161 30…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 3 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1926-2025%22
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