Beckman Coulter recalls DxI 800 Access Immunoassay Analyzers with specific serial numbers due to software issues causing potential delays in patient test results.
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 certain DxI 800 Access Immunoassay Analyzers that have software versions 5.7 and above. The issue causes incorrect motor settings which might delay patient test results if not noticed.
The software overwrites the factory motor settings during installations or upgrades, causing the X-motor current to reset to 1.5A instead of the required 2.0A. This leads to increased motion errors that could delay patient test results if the issue goes unnoticed.
Healthcare facilities using the recalled DxI 800 Access Analyzers with specific serial numbers and software versions 5.7 and above are most at risk. The recall affects laboratory equipment used for patient testing.
Check if your DxI 800 Access Immunoassay Analyzer has serial numbers listed in the provided list (e.g., 609821, 609831) and software version 5.7 or higher.
Verify your device's software version; if it is 5.7 or higher, it may be affected.
The software overwrites the factory motor settings during installations or upgrades, causing the X-motor current to reset to 1.5A instead of the required 2.0A.
Increased motion errors could lead to delays in reporting patient sample results if the issue goes unnoticed.
Check if your device has a serial number in the provided list and software version 5.7 or higher. If so, contact Beckman Coulter for further instructions.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2268-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2268-2025 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.
