Beckman Coulter recalls DxC 500i Clinical Analyzer Modules with software version 1.5 or lower that may generate incorrect patient test results when 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 500i Clinical Analyzer Modules using software version 1.5 or lower. This software defect causes user-customized test rules to revert to default settings silently, potentially creating incorrect patient test results without warning.
The software defect overwrites user-customized test rules when a new Parameter Package is imported. This causes the system to revert to default settings without warning, potentially generating incorrect patient test results.
Healthcare facilities using Beckman Coulter DxC 500i Clinical Analyzer Modules with software version 1.5 or lower are affected. Laboratory staff and patients using these systems are at risk of receiving incorrect test results.
Check if your DxC 500i Clinical Analyzer Module has software version 1.5 or lower. Look for part numbers C63522, C63521, or C13252 on the device.
Verify your DxC 500i Clinical Analyzer Module's software version to ensure it is not 1.5 or lower.
The software defect causes user-customized test rules to revert to default settings silently when importing new Parameter Packages, potentially generating incorrect patient test results.
Check for part numbers C63522, C63521, or C13252 on your DxC 500i Clinical Analyzer Module, or software version 1.5 or lower.
The recall does not specify a remedy, so contact Beckman Coulter 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-2973-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2973-2026 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.
