Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software versions 1.20.0 or older that may lose connection to lab systems, delaying patient test results and treatment.
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
Take action
Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
“Beckman Coulter DxI 9000 Access Analyzer: Lost Connections Delay Patient Treatment.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52532-beckman-coulter-dxi-9000-access-analyzer-lost-connections-delay-patient. Based on FDA recall #Z-1664-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1664-2025%22&limit=1).
The FDA announced on March 27, 2025, that Beckman Coulter, Inc. is recalling its DxI 9000 Access Immunoassay Analyzers because the devices may lose communication with host systems, interrupting sample processing and delaying patient test results. The agency classified this as a Class II recall affecting 370 units distributed worldwide.
How to tell if you have it
Brand: Beckman Coulter
Product: DxI 9000 Access Immunoassay Analyzer
UDI/DI: 15099590732103
Software versions: SW 1.20.0 and below
The hazard
When connected to a host system such as a laboratory information system or middleware, the analyzer may lose communication if it has accumulated canceled QC test results not sent by the LIS. This lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500 AU Modules with Software 1.5 Risk Patient Test Errors (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit: Incorrect Algorithms May Affect Test Results (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect Treatment (March 16, 2026). Additional similar recalls include Beckman Coulter DxC 700 AU Recall: Delay in Results May Cause Diagnosis Delays (Jan. 30, 2026), Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results Risk (Jan. 30, 2026), and AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results (Aug. 3, 2026).
How to tell if you have this one
Check if your DxI 9000 Access Immunoassay Analyzer has software version 1.20.0 or older. The device has a unique identifier (UDI/DI) starting with 15099590732103.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Contact Beckman Coulter to update the software to version 1.20.1 or newer to fix the connection issue.
How this recall unfolded
Recall timeline
FDA published this recall 34 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-1664-2025 (March 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1664-2025 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.