Beckman Coulter recalls UniCel DxI 600 Access Immunoassay Analyzers with specific software versions due to potential motion errors that could delay patient test results. Affected units have unique serial numbers listed in the recall.
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 UniCel DxI 600 Access Immunoassay Analyzers that run software versions 5.7 and later. This issue could cause motion errors in the device, potentially delaying patient test results if not corrected.
The software incorrectly sets the X-motor current to 1.5A instead of the required 2.0A during installations or upgrades. This causes increased motion errors that might delay patient test results if the issue goes unnoticed.
Healthcare facilities using the UniCel DxI 600/800 systems with specific software versions (5.7 and later) are affected. Laboratories that have the listed serial numbers or part numbers are most at risk.
Check if your UniCel DxI 600 Access Immunoassay Analyzer has software version 5.7 or later. Affected units have specific serial numbers listed in the recall notice.
Verify your device's software version; affected units run version 5.7 or later.
Beckman Coulter identified that the software incorrectly sets the X-motor current to 1.5A instead of 2.0A, causing potential motion errors that could delay patient test results.
Check if your UniCel DxI 600 Access Immunoassay Analyzer has software version 5.7 or later and a serial number from the list provided in the recall notice.
The recall notice does not specify a remedy, so contact Beckman Coulter directly for guidance on next steps.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2269-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2269-2025 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.
