Recall Monitor
Health Products

DxC 500i Clinical Analyzers

· Published by Health Canada · Official notice

Details

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

Affected productsLot or serial numberModel or catalogue number
DxC 500i Clinical Analyzer, DxC 500i Au Chemistry Modulesoftware 1.3.3 or 1.3.4C63522
DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Modulesoftware 1.3.3 or 1.3.4C13252

Issue

Beckman Coulter has determined that on the DxC 500i clinical analyzer, when ordering a clinical chemistry (CC) combination test simultaneously with an immunoassay (IA) test, if the IA test is processed between the CC constituent tests, the sample status of the CC test will remain "in progress" with no error events. Recall start date: August 4, 2025

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