Beckman Coulter Inc. recalls Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower:

Recalling company

Beckman Coulter Inc.

Product

Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jul 15, 2026

Reported

Aug 26, 2026

Distribution

Worldwide distribution - US Nationwide.

Status

Ongoing

Lot / codes

1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065

Company location

Brea, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-2974-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2974-2026 in the FDA Enforcement Report. Also see FDA recall press releases.