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.
Beckman Coulter is recalling DxI 800 Access Immunoassay Analyzers with certain serial numbers because a software issue causes motor settings to reset incorrectly. This could delay patient test results if not fixed.
The software overwrites the factory motor current setting to 1.5A instead of 2.0A during installations or upgrades. This causes increased motion errors in the analyzer, which could lead to delays in reporting patient test results if the error is not detected.
Healthcare facilities using the DxI 800 analyzer with specific serial numbers are most at risk. Patients may experience delayed test results if the issue goes unnoticed.
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.
Look for serial numbers starting with 608109 on the DxI 800 analyzer.
Beckman Coulter identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up have incorrect PnP X-motor current settings that could delay patient test results.
Check if your DxI 800 analyzer has a serial number starting with 608109. If affected, contact Beckman Coulter for further instructions.
The recall record does not specify a remedy or fix for the issue.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2267-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2267-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
