Product Wiki · Recalls · Health Canada — Medical Devices

System Control N+P, STA — recall 47990

Health Canada — Medical Devices · Canada · 2019-12-13 · Type III

As described by Health Canada — Medical Devices: System Control N+P, STA - Coag Control N+P & Unicalibrator - STA (2019-11-19)

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Agency
Health Canada — Medical Devices
Recall identifier
47990
Date of alert
2019-12-13
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Following a customer complaint, Stago has investigated and confirmed that a positive bias exists on the STA - Unicalibrator levels with STA - deficient IX and STA - deficient VIII when compared to the international Standard (IS) for factor VIII or IX. This bias is also observed on several external quality assessment results.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/system-control-np-sta-coag-con

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