FDAFDA recall Z-2973-2026 · Aug 26, 2026

Beckman Coulter Inc.: Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1 recall

Recall found

Product

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers

Reason for recall

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 1) Part Number C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331.
Distribution: Worldwide distribution - US Nationwide.
Recalling firm: Beckman Coulter Inc., Brea, CA
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-07-15

Source: openFDA enforcement record Z-2973-2026 · search recall number Z-2973-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.