Quality & complianceOfficial

Beckman Coulter warns DxC 500 AU analyzers can silently revert test units to default

🇳🇱 IGJ · Tue 03 Nov 2026

A software issue on DxC 500 AU Clinical Chemistry Analyzers may reset custom test units to system defaults without telling users, according to a field safety notice published by the Dutch inspectorate IGJ.

The Dutch healthcare inspectorate IGJ has published a manufacturer warning from Beckman Coulter about a software problem on its DxC 500 AU Clinical Chemistry Analyzers. The issue concerns the testing of plasma samples.

According to the notice, the problem can arise when a user has set up a Clinical Chemistry test with units that differ from the system default. If the configuration is subsequently changed and the draft configuration is activated on the System Configuration page, the analyzer may switch the test's units back to the default setting. The user is not alerted when this happens.

The field safety notice (FSN) is dated 27 August 2026, and IGJ's posting carries a date of 4 November 2026. The device is listed as a Clinical Chemistry Analyzer, with Beckman Coulter Ireland Inc. named as the authorised representative. The three-page document is available from IGJ as a PDF.

The text provided does not set out the corrective actions requested of users or describe the clinical impact of the unit reversion, so those details should be taken from the full notice. As general context, manufacturers issue FSNs when post-market surveillance identifies a risk, and they inform both users and the competent authority.

What it means for your team

  • Laboratories using DxC 500 AU analyzers should read the full FSN to confirm the required actions and the exact scope of affected configurations.
  • Labs that run plasma tests with non-default units should check whether any configuration changes have been activated and whether the units still match the intended settings.
  • Quality teams may wish to review results produced after relevant configuration changes, in line with their own procedures and the manufacturer's instructions.
  • Vigilance and compliance teams should log the notice and keep records of how it was assessed and handled.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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