Lower riskMedical device recall · FDA · Published June 25, 2025
Beckman Coulter DxI 800 Analyzer Recall: Incorrect Motor Settings May Delay Results
Beckman Coulter recalls DxI 800 Access Immunoassay Analyzers with specific serial numbers due to incorrect motor settings that could delay patient test results. Affected units may require correction to prevent reporting errors.
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
Take action
Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
“Beckman Coulter DxI 800 Analyzer Recall: Incorrect Motor Settings May Delay Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51961-beckman-coulter-dxi-800-analyzer-recall-incorrect-motor-settings-may. Based on FDA recall #Z-2267-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2267-2025%22&limit=1).
The FDA announced on June 25, 2025, that Beckman Coulter, Inc. is recalling one DxI 800 Access Immunoassay Analyzer with dual gantry due to incorrect motor current settings. This defect may cause delays in reporting patient sample results if unnoticed.
Beckman Coulter identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up face incorrect PnP X-motor current settings where the current resets to 1.5A instead of the required 2.0A. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
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 500i Modules with Software 1.5 Risk: Erroneous Test Results (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11: 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). Other recent recalls of similar products 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 Beckman Coulter Emit 2000 Quinidine Assay Recall: Risk of Incorrect Patient Treatment (July 13, 2026).
How to tell if you have this one
Check for serial numbers starting with 608109 on the DxI 800 analyzer. The product was sold with specific part number A71457 and UDI-DI: 15099590369231.
Brand
Beckman Coulter
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
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-2267-2025 (June 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2267-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.