Product Wiki · Recalls · Health Canada — Medical Devices

Human IgM kit for use on SPAPLUS (2018-07-25) — recall 58157

Health Canada — Medical Devices · Canada · 2018-08-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58157
Date of alert
2018-08-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Following the receipt of an external complaint a review was held at the binding site on 13/07/2018. Investigations at the binding site indicate that after running the calibration curve the recovery of the kit control results decrease by approximately 12% within the same day. Samples have been shown to be similarly affected.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/human-igm-kit-use-spaplus-2018

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