Official recall record

DxC 500 AU Clinical Chemistry Analyzer (ref 77176)

Health Canada — Medical Devices · 2025-03-25 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-03-25
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

Beckman Coulter has determined that the DxC 500 AU Clinical Chemistry Analyzer may not run a requested calibration order for a two-part reagent and subsequently prevents any new calibration order from being placed. For two-part reagents, when reagent blank or calibration is ordered during sample processing and then any of the components (r1 and/or r2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. The analyzer will not allow additional calibration orders to be requested for any assays. Recall Start Date: March 12, 2025

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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