Product Wiki · Recalls · Health Canada — Medical Devices

Advia Centaur System - Calibrators — recall 57052

Health Canada — Medical Devices · Canada · 2017-07-07 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
57052
Date of alert
2017-07-07
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: Confirmed a negative bias for Advia Centaur Enhanced Estradiol (EE2) on the Advia Centaur, Advia Centaur XP and Advia Centaur XPT Systems when calibrating with calibrator 30 kit lots ending in 21 (C3021) as compared to calibrator 30 kit lots ending in 20 (C3020).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-system-calibrato

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