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Coulter DxH Diluent — recall 81285

Health Canada — Medical Devices · Canada · 2025-11-26 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 81285
Date of alert: 2025-11-26
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices

Reported risk: Beckman Coulter has confirmed that specific diluent lot numbers of Coulter DxH Diluent contribute to elevated platelet (PLT) Daily Checks background counts cycle when used with the UniCel DxH 600/690T/800/900 analyzers. This may result in elevated PLT background counts in Daily Checks ranging from 3.0 to 9.1 x 10 3 cells/μL.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/coulter-dxh-diluent-0

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Coulter DxH Diluent — recall 81285

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