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FDA · Medical devices ·

Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower recall

Beckman Coulter Inc. recalled Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower on August 26, 2026 because of 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. 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 P…

What's recalled

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

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Beckman Coulter Inc., Brea, CA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide distribution - US Nationwide.
Status
Ongoing
Recall number
Z-2973-2026
Source
U.S. Food and Drug Administration

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