Product Wiki · Recalls · Health Canada — Medical Devices

DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer — recall 78147

Health Canada — Medical Devices · Canada · 2025-09-26 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
78147
Date of alert
2025-09-26
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: Beckman Coulter has confirmed a software anomaly on the DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results (R1, R2) and potential delays in reporting (R3), risking erroneous diagnoses if undetected
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dxc-500i-clinical-analyzer-and

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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