Recall Monitor
Health Products

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 500 AU Clinical Chemistry Analyzer
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 catalog number
DxC 500 AU Clinical Chemistry Analyzer2024070118C63520
C63519

Issue

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

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