Recall Monitor
Health Products

Dxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry Analyzer

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Dxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry Analyzer
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Dxc 500i Clinical AnalyzerSoftware V. 1.3.5 or earlierC63521
Dxc 500i Clinical AnalyzerSoftware V. 1.3.5 or earlierC63522
Dxc 500 AU Clinical Chemistry AnalyzerSoftware V. 1.4.5 or earlierC63520
Dxc 500 AU Clinical Chemistry AnalyzerSoftware V. 1.4.5 or earlierC63519

Issue

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.

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