Beckman Coulter DxC Analyzers Recalled Over Software Flaw: Health Canada

A software defect in two widely used clinical chemistry analyzers could cause laboratory results to display in the wrong measurement units without any warning to the technician reading them — a glitch that Health Canada says is serious enough to trigger a formal medical device recall. The issue affects the DxC 500i Clinical Analyzer and the DxC 500 AU Clinical Chemistry Analyzer, both manufactured by Beckman Coulter, Inc.

According to the recall notice published by Health Canada, the manufacturer identified the problem while testing plasma samples on the two analyzer models. If a user configures a chemistry test to use nondefault measurement units, and a draft configuration is later activated from the system configuration page, the software may silently revert the units back to the system default. Because the change happens without notifying the operator, lab staff could unknowingly read results in the wrong units.

What Products Are Being Recalled?

The recall covers four specific configurations of the two analyzer lines. The ‘Dxc 500i Clinical Analyzer’ is affected under model or catalogue numbers C63521 and C63522, running software version 1.3.5 or earlier. The ‘Dxc 500 AU Clinical Chemistry Analyzer’ is affected under model or catalogue numbers C63520 and C63519, running software version 1.4.5 or earlier. Any unit still operating on these software versions falls within the scope of the recall.

Why Was This Recall Issued?

Health Canada classified the action as a Type II recall, a category generally used when a product defect could cause temporary or medically reversible health consequences, or where the probability of serious harm is remote. In this case, the concern centers on data integrity: clinical decisions are often made based on the exact numeric value and unit of a lab result, and a silent, unannounced shift in units on a plasma test could lead to misinterpretation by healthcare providers. The recall notice lists the issue category as ‘Medical devices – Performance,’ underscoring that this is a functional software flaw rather than a hardware or contamination hazard.

Who Should Be Concerned

This recall is directed at healthcare and industry audiences rather than individual consumers. Hospitals, clinical laboratories, and diagnostic facilities in Canada that operate either analyzer model — particularly those running the affected software versions — are the intended recipients of this alert. Beckman Coulter is headquartered at 250 S. Kraemer Blvd., Brea, California, and the recall was published by Health Canada with an original issue date of September 10, 2026, though the underlying recall date is listed as August 26, 2026.

What Should You Do?

Health Canada’s guidance for this alert is direct: facilities using either device should contact the manufacturer if they require additional information. Beckman Coulter is expected to provide affected facilities with guidance on verifying software versions, checking configuration settings, and applying any necessary corrective steps to prevent the unit-reversion issue from occurring undetected. Laboratories are advised to review recent plasma test results generated on affected units for unit consistency while awaiting manufacturer guidance.

Regulatory Response

Health Canada assigned the alert identification number RA-82613 and listed the recall under its Health products – Medical devices – Chemistry category. The recall record notes that Beckman Coulter identified the software issue itself, and Health Canada’s public notice is intended to ensure that all healthcare and industry users of the DxC 500i and DxC 500 AU systems in Canada are made aware of the defect and can take appropriate precautions. Health Canada continues to monitor medical device recalls and encourages facilities to report any related concerns through its official health and safety concern reporting channel.

No further product retrieval, refund, or disposal instructions were listed in the notice, as this recall centers on a software correction rather than a physical product defect requiring return.