Beckman Coulter DxC 500 Clinical Chemistry Analyzers
DxC 500 AU and DxC 500i analyzers have a software issue that can revert test units to default without warning, causing falsely elevated results.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Beckman Coulter Inc. recalled DxC 500 AU Clinical Chemistry Analyzers and DxC 500i Clinical Analyzer Modules due to a software issue affecting 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 may cause the analyzer to revert test units to the system default without notifying the user, resulting in falsely elevated reported results.
The recall began September 2, 2026, and was classified by the FDA on October 2, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the list below, then check the codes the FDA notice also names.
DxC 500 AU Clinical Chemistry Analyzers
Reason: Beckman Coulter has identified a software issue affecting DxC 500 AU 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.
- UDI-DI
- 14987666545058
- 14987666545065
DxC 500i Clinical Analyzer Modules
Reason: 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.
- UDI-DI
- 14987666545089
- 14987666545072
- 15099590742331
From the FDA notice
DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522
DxC 500 AU Module, DxC 500i, Part No. C63521
Access 2 Module, DxC 500i, Part No. C13252
Details
- Company began the recall
- Event ID
- 99800
- Company
- Beckman Coulter Inc.
- Hazard
- Software defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report