Product Wiki · Recalls · Health Canada — Medical Devices

EliA SmDp Well (2015-12-28) — recall 54762

Health Canada — Medical Devices · Canada · 2016-01-28 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54762
Date of alert
2016-01-28
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Analysis of patient samples received in complaint investigations showed that several samples caused unspecific signals up to 22 U/mL. The unspecific signals are neither caused by anti-Sm antibodies nor by anti-streptavidin antibodies but are due to other unspecific signals with an as yet unknown cause.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/elia-smdp-well-2015-12-28

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