FDA Device recall Z-1913-2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
- FDA Device
- Class II
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 by Beckman Coulter, citing 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 requir….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1913-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-23 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Reason
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.
Identifiers
| code_info | UDI-DI: 15099590732103; Serial Numbers: 300573 300572 300571 300570 300569 300568 300567 300566 300564 300563 300562 30…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 3 |
|---|
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-1913-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.