Product Wiki · Recalls · Health Canada — Medical Devices

TPHA Screen Test Cells — recall 56700

Health Canada — Medical Devices · Canada · 2017-06-12 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56700
Date of alert
2017-06-12
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: Immucor, Inc. is issuing this medical device recall regarding the stability of the TPHA screen test cells, lot 280006. A review of post-release testing demonstrated this lot of TPHA screen test cells had a decrease in sensitivity for detection of antibodies to treponema pallidum over the product's shelf life.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/tpha-screen-test-cells

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