Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software version 1.20 that may cause assay errors and delayed results due to incorrect motor/encoder installation.
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.
Take action
Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
“Beckman Coulter DxI 9000 Access Analyzer Software Error Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52426-beckman-coulter-dxi-9000-access-analyzer-software-error-recall. Based on FDA recall #Z-1926-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1926-2025%22&limit=1).
Beckman Coulter, Inc. recalled DxI 9000 Access Immunoassay Analyzers on April 23, 2025, according to the FDA. The recall addresses incorrect motor/encoder installations that introduce error codes and delay test results. Owners should contact the company for resolution.
How to tell if you have it
Brand: Beckman Coulter
Product: DxI 9000 Access Immunoassay Analyzer
Catalog Number: C11137
Software versions: 1.20
Serial Numbers: 300144 through 300573 (specifically listed in record)
Quantity: 324 units
The hazard
The recall involves instruments manufactured starting with serial number 300141 where a new motor/encoder and cable were incorrectly installed. This error introduces codes for the DxI 9000 that prevent assays from being performed and delay result generation, potentially requiring field service.
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 AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results (Aug. 3, 2026), Beckman Coulter DxC 700 AU Recall: Delay in Results May Cause Diagnosis Delays (Jan. 30, 2026), and Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results Risk (Jan. 30, 2026).
How to tell if you have this one
Check if your DxI 9000 Access Immunoassay Analyzer has software version 1.20 and serial numbers listed in the recall (e.g., 300144, 300145, etc.).
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your analyzer's software version is 1.20 and check the serial number against the list provided in the recall.
Contact Manufacturer
Reach out to Beckman Coulter for field service assistance if your analyzer shows error codes or delayed results.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of China, India, United Kingdom of Great…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 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-1926-2025 (April 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1926-2025 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.