Lower riskMedical device recall · FDA · Published July 15, 2026
Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results
Beckman Coulter recalls DxC 500i Clinical Analyzer Modules with software version 1.5 or lower that may generate incorrect patient test results when importing new Parameter Packages.
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.
✎ GovInfoNow plain-language explainer
Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules using software version 1.5 or lower. This software defect causes user-customized test rules to revert to default settings silently, potentially creating incorrect patient test results without warning. Read more at govinfonow.com/recall/697870-beckman-coulter-dxc-500i-modules-with-software-1-5-risk.
“Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697870-beckman-coulter-dxc-500i-modules-with-software-1-5-risk. Based on FDA recall #Z-2973-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2973-2026%22&limit=1).
The FDA announced on July 15, 2026, that Beckman Coulter Inc. is recalling DxC 500i Clinical Analyzer Modules with software version 1.5 or lower due to a software defect that may generate erroneous patient test results.
How to tell if you have it
DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522
DxC 500 AU Module, DxC 500i, Part Number C63521
Access 2 Module, DxC 500i, Part Number C13252
The hazard
According to the FDA, a software defect in the Parameter Package import logic overwrites all predefined calculated test rules, including user-modified ones, upon importing a new version. This causes user-customized rules to silently revert to default expressions, potentially generating erroneous patient test results without an explicit error notification.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Recent similar recalls include the Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026), the Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026), and the Beckman Coulter CellMek SPS Sample Prep System Software Error Risk (December 23, 2025). Other recent recalls of similar products include the Beckman Coulter REMISOL Advance Software Issue (April 29, 2026), the Beckman Coulter DxC 700 AU Recall (January 30, 2026), and the Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026).
How to tell if you have this one
Check if your DxC 500i Clinical Analyzer Module has software version 1.5 or lower. Look for part numbers C63522, C63521, or C13252 on the device.
Brand
Beckman Coulter
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide.
Recall number
Product, codes & lots
Quantity
Z-2973-2026
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; 1) Part Number C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331.
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Z-2974-2026
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; 1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065
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Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your DxC 500i Clinical Analyzer Module's software version to ensure it is not 1.5 or lower.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2973-2026 (July 15, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2973-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.