Beckman Coulter recalls DxI 600 Access Immunoassay Analyzers with specific serial numbers due to incorrect motor current settings that could delay patient test results. Affected units may require software updates 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 certain DxI 600 Access Immunoassay Analyzers because a software issue causes motor current settings to reset incorrectly, potentially delaying patient test results. This could lead to inaccurate or delayed 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 motion errors that might delay patient test results if the problem goes unnoticed.
Healthcare facilities using the recalled DxI 600 analyzers with specific serial numbers are most at risk. The issue affects laboratory equipment that processes patient samples.
Check for the part number A71461 and serial numbers starting with 902101. The recall applies to specific units sold with UDI-DI: 15099590369248.
Verify the software version is 5.7 or higher on the DxI 600 analyzer.
Reach out to Beckman Coulter for guidance on software updates or other remedies.
The software incorrectly sets the X-motor current to 1.5A instead of 2.0A, which can cause motion errors and delay patient test results.
No, the recall does not require immediate discontinuation. Affected units may continue operating with software updates.
Check for part number A71461 and serial numbers starting with 902101. The recall applies to units with UDI-DI: 15099590369248.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2270-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2270-2025 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.
