Product Wiki · Recalls · Health Canada — Medical Devices

Coulter Body Fluid Control Level 1 — recall 56291

Health Canada — Medical Devices · Canada · 2016-11-16 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56291
Date of alert
2016-11-16
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 identified an issue with the Coulter Body Fluid Control Level 1 resulting in customers recovering high and/or out of range values for the total nucleated cells (TNC) as compared to the published table of expected results.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/coulter-body-fluid-control-lev

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