Product Wiki · Recalls · Health Canada — Medical Devices

Liaison EBV IgM (2015-08-04) — recall 54300

Health Canada — Medical Devices · Canada · 2015-10-22 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
54300
Date of alert
2015-10-22
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: Recall initiated due to observed trend which may cause the potential for false positive results. Internal testing confirmed the kit performance is meeting performance claims. EBV-IgM (Esptein-Barr Virus Immunoglobulin) results should not be used alone but in conjunction with other EBV serological markers to determine disease state.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/liaison-ebv-igm-2015-08-04

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