Product Wiki · Recalls · Health Canada — Medical Devices

Anti-Saccharomyces Cerevisiae Antibodies (Asca) Iga Test — recall 57058

Health Canada — Medical Devices · Canada · 2017-07-11 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57058
Date of alert
2017-07-11
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: It has been observed recently that the values of some samples tested with the autoimmune EIA ASCA IgA test decreased significantly when compared to the values of the same set of samples tested with another lot of autoimmune EIA ASCA IgA test. This observation was confirmed by subsequent testing with a different set of samples. The observed decrease in sample value presents a potential for increase in false negative results.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/anti-saccharomyces-cerevisiae-

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