DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module recallZ-2973-2026 · Beckman Coulter Inc. · initiated Jul 15, 2026

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.

FDA root cause category: Software design (manufacturing process)

What the company is doing

Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice (dated 7/10/26) to its consignees on 7/15/2026 via USPS and/or email. The notice explained the issue, impact, and requested the following: The customers are advised to: " Do not change any of the 25 predefined calculated rules. In the case that the default expression does not meet the laboratory s requirements, Beckman Coulter has developed a Job Aid, which outlines the workflow required if laboratories require calculated test rules outside of those predefined calculated rules. " Consult with the Laboratory Manager and/or Medical Director to determine whether any of the predefined rules in the table were modified from the default expression during or following analyzer installation. o If no default expression was modified, there is no action to be taken. o If a predefined calculated rule was modified as compared with the default expressions in the table, follow the steps in the letter to configure this rule as a custom calculated rule in System configuration and to disable the predefined calculated rule that was modified. " Share the letter with the Medical Director to determine if performing a retrospective review of results is necessary. " Post the letter on or near the affected analyzers. For questions regarding this notice, please contact our Customer Support Center. " From our website: http://www.beckmancoulter.com " By phone: call 1-800-854-3633 in the United States and Canada. o Outside the United States and Canada, contact your local Beckman Coulter representative.

Recall details

Recall number

Z-2973-2026

Status

Open, Classified

Initiated by the company

Jul 15, 2026

Posted by the FDA

Aug 17, 2026

Recalling firm

Beckman Coulter Inc.

Product code

JJE

FDA submissions

K242190

Distribution

Worldwide distribution - US Nationwide.

Product description

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

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module C63522

  Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  4 recalls5 reports
• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module C63521

  Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  4 recalls0 reports
• DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module C13252

  Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
  3 recalls3 reports

Product lines

• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry ModuleBeckman Coulter, Inc. · 2 models · 5 reports · 4 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 99436).

• Z-2974-2026 · Open, Classified
  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 Clinic…