Product Wiki · Recalls · Health Canada — Medical Devices

Quanta Lite h-tTG IgG Elisa (2014-02-17) — recall 51296

Health Canada — Medical Devices · Canada · 2014-04-04 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
51296
Date of alert
2014-04-04
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: The low positive control included in the kit can fail to generate sufficient reaction to meet the minimum optical density required by the direction insert. This would result in an invalid test and therefore, no results would be reported. Any results already reported with acceptable QC criteria are not impacted by this recall.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/quanta-lite-h-ttg-igg-elisa-20

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