Beckman Coulter DxC 500i Clinical Analyzer recalled for software test unit configuration error
What this means
A software issue in Beckman Coulter's DxC 500i Clinical Analyzer can cause test units to revert to system defaults without alerting the user after certain configuration changes. This silent reversion can result in test results being reported with incorrect units, leading to falsely elevated values that may not be caught by clinical staff.
- Check if your DxC 500i analyzer is running software version 1.3.5 or earlier
- Contact Beckman Coulter for a software update and instructions
- Review recent test results from affected analyzers for accuracy
- Verify test unit settings are correct before activating configuration changes
The agency's original wording
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2027More Beckman Coulter recalls
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