Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with specific firmware versions that may cause delays in patient result reporting. Affected units include those with PCB, TSI/RSI firmware C29278 and catalog number C11137.
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.
Take action
Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
“Beckman Coulter DxI 9000 Analyzer Recall: Firmware Delay Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52957-beckman-coulter-dxi-9000-analyzer-recall-firmware-delay-risk. Based on FDA recall #Z-1387-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1387-2025%22&limit=1).
The FDA announced on Feb. 6, 2025, that Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers due to firmware issues causing sub-system communication failures. This defect could result in a delay in reporting patient results.
How to tell if you have it
Brand: Beckman Coulter
Product: DxI 9000 Access Immunoassay Analyzer
Catalog Number: C11137
Component PCB, TSI/RSI firmware C29278
UDI-DI: 15099590732103
Serial Numbers: 300158 through 300389 (specific list provided)
Units affected: 80
The hazard
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.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since 2017-06-20. Recent brand-specific recalls include the DxC 500i Modules with Software 1.5 (2026-07-15), MicroScan LabPro V5.03 Panel Update 11 DVD Kit (2026-06-26), and Access Total T4 Calibrator Recall (2026-03-16). Other recent recalls of similar products include the DxC 700 AU Recall (2026-01-30), AU5800 Chemistry Analyzer Recall (2026-01-30), and Emit 2000 Quinidine Assay Recall (2026-07-13).
How to tell if you have this one
Check if your DxI 9000 analyzer has the catalog number C11137 and firmware version C29278. The serial numbers listed in the recall notice include specific numbers like 300158, 300161, and others.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Firmware Version
Verify your DxI 9000 analyzer's firmware version by checking the PCB, TSI/RSI firmware number. If it matches C29278, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of FL, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Texas, Washington.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1387-2025 (February 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1387-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.