Product Wiki · Recalls · Health Canada — Medical Devices

Immulite 2000 System - Total IgE Assay (2013-12-27) — recall 50633

Health Canada — Medical Devices · Canada · 2014-02-11 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50633
Date of alert
2014-02-11
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Siemens Healthcare Diagnostics has confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the Immulite Systems Total LGE assays. The Immulite Total LGE controls (IECA1,2) will not detect the bias.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/immulite-2000-system-total-ige

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