Beckman Coulter Inc.: Analyzer, Chemistry (photometric, Discrete), For Clinical Use

Recall Summary Beckman Coulter is recalling certain DxC 500i and DxC 500 AU Clinical Chemistry Analyzer modules running software version 1.5 or lower due to a software defect that can erase customized test settings when new parameter packages are imported. This defect may cause the analyzers to silently produce incorrect patient test results without alerting users to the problem. The recall affects hospitals and clinical laboratories nationwide that use these devices and have previously modified their test settings.

Recalling firm

Beckman Coulter Inc.

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

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;...

Classification

Class I

Category

medical device recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-07-15

Status

Open, Classified

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Worldwide distribution - US Nationwide.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/533ef3a9-be34-4806-b52e-0568efdf34ac