Product Wiki · Recalls · Health Canada — Medical Devices

ROCHE DIAGNOSTICS ESTRADIOL (2016-03-08) — recall 54694

Health Canada — Medical Devices · Canada · 2016-03-29 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54694
Date of alert
2016-03-29
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The reason for the recall is related to a situation where the manufacturer has identified during an internal investigation, that the substance fulvestrant may lead to falsely elevated results in the Elecsys Estradiol II and Elecsys Estradiol III assays.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/roche-diagnostics-estradiol-20

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