Beckman Coulter DxC 500i and DxC 500 AU Analyzers Recall Over Software Unit Reversion Issue

Source: Health Canada · Canada

Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.

Beckman Coulter is recalling DxC 500i and DxC 500 AU Clinical Chemistry Analyzers due to a software issue that may revert test units to default without user notification.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on September 10, 2026 and geographically references Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, medical-device.

What Happened

Beckman Coulter identified a software issue affecting DxC 500i and DxC 500 AU Analyzers when testing plasma samples. Following user configuration of a chemistry test to nondefault units, subsequent activation of a draft configuration in the system configuration page may revert units to the system default without notifying the user.

Which Products Are Affected

  • DxC 500i Clinical Analyzer, Software V. 1.3.5 or earlier, model C63521
  • DxC 500i Clinical Analyzer, Software V. 1.3.5 or earlier, model C63522
  • DxC 500 AU Clinical Chemistry Analyzer, Software V. 1.4.5 or earlier, model C63520
  • DxC 500 AU Clinical Chemistry Analyzer, Software V. 1.4.5 or earlier, model C63519

Affected products are manufactured by Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, California, United States, 92821.

What You Should Do

Users should verify system configurations after activating draft settings and contact Beckman Coulter for additional guidance on the software issue.

Why This Matters

The software issue could affect the accuracy of chemistry test results on plasma samples without alerting the user.

Source

Health Canada

Original source: Health Canada Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Beckman Coulter is recalling DxC 500i and DxC 500 AU Clinical Chemistry Analyzers due to a software issue that may revert test units to default without user notification.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.