Reported Aug 26, 2026 · Ongoing · Updated Sep 7, 2026
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5
- or lower
1) AU w/out ISEPart Number C635192) AU w/ISEPart Number C63520DxC 500 AU Clinical Chemistry Analyzers
- Lot codes and dates
1) Part Number C63519UDI/DI 14987666545058 2) Part Number C63520UDI/DI 14987666545065
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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