Beckman Coulter DxC 500 AU Clinical Analyzer recalled for software defect causing incorrect test results
What this means
A software defect in Beckman Coulter's DxC 500 AU Clinical Analyzer (software version 1.5 or lower) can silently overwrite customized test calculation rules when a new Parameter Package is imported. This may cause the analyzer to generate incorrect patient test results without alerting the operator to the problem. The issue only occurs when updating an existing system; newly installed systems are not affected.
- If you operate a DxC 500 AU Analyzer with software version 1.5 or lower, do not import a new Parameter Package without first reviewing and re-verifying all custom calculated test rules.
- Contact Beckman Coulter for guidance on upgrading to a patched software version or for instructions on safe Parameter Package updates.
- Review recent test results and patient data if a Parameter Package import occurred; consider revalidating affected tests.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2974-2026Want us to check the next one for you?
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