Product Wiki · Recalls · Health Canada — Medical Devices

Unicel DXH 600 and Unicel DXH 800 Coulter Cellular Analysis Systems… — recall 51551

Health Canada — Medical Devices · Canada · 2014-04-14 · Type III

As described by Health Canada — Medical Devices: Unicel DXH 600 and Unicel DXH 800 Coulter Cellular Analysis Systems (2014-03-06)

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Agency
Health Canada — Medical Devices
Recall identifier
51551
Date of alert
2014-04-14
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Beckman Coulter has confirmed that when reporting units are not configured in US-1 and a Delta check limit is set up using a difference value, the Unicel DXH 800 and Unicel DXH 600 system manager may under or over generate Delta check flags. The issue does not apply to Delta checks configured using percent difference limits. Delta checks performed at the laboratory information system (LIS) are not affected. Patient results are not affected.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxh-600-and-unicel-dxh-

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