Beckman Coulter Inc.: 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

Recall number

Z-2974-2026

Recalling firm

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

Status

Open, Classified

Initiated

2026-07-15

Posted

2026-08-17

Terminated

not on file

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.

Root cause

Software design (manufacturing process)

Action

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.

Quantity

not on file

Distribution

Worldwide distribution - US Nationwide.

Lot, serial or model codes

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

510(k) numbers

["K220977"]

PMA numbers

not on file

Product code

JJE

Firm FEI

2050012

Firm city

Brea

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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