Beckman Coulter recalls DxC 500 AU Clinical Analyzer Modules with software version 1.5 or lower that may generate incorrect patient test results after importing new parameter packages.
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.
Beckman Coulter is recalling DxC 500 AU Clinical Analyzer Modules with software version 1.5 or lower. These modules may revert user-customized test rules to default settings when a new parameter package is imported, potentially causing incorrect patient test results.
The software defect causes user-customized test rules to silently revert to default settings when a new parameter package is imported. This can generate incorrect patient test results without warning. The issue only occurs when an existing parameter package is already installed on the system.
Healthcare professionals using Beckman Coulter DxC 500 AU Clinical Analyzer Modules with software version 1.5 or lower are most at risk. This affects specific model parts with part numbers C63519 and C63520.
Check if your DxC 500 AU Clinical Analyzer Module has software version 1.5 or lower. Look for part numbers C63519 (AU without ISE) or C63520 (AU with ISE).
Verify your DxC 500 AU Clinical Analyzer Module's software version to ensure it is not 1.5 or lower.
Software version 1.5 or lower.
Part numbers C63519 (AU without ISE) and C63520 (AU with ISE).
No, new installations are not affected by this 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-2974-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2974-2026 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.
