Product Wiki · Recalls · Health Canada — Medical Devices

Monolisa Hcv Ag-Ab Ultra V2 — recall 74735

Health Canada — Medical Devices · Canada · 2023-12-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74735
Date of alert
2023-12-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Microbiology
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: During an internal assessment, sensitivity to the HCV antigen was reduced for samples near the detection limit. Due to the reduced sensitivity of the HCV antigen test, recent infections by HCV cannot be detected in patient samples as early as with previous lots of Monolisa HCV Ag-Ab ULTRA V2. For these lots, there is no impact on the detection of seroconversions of antibodies against HCV. Recall start date: December 1, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/monolisa-hcv-ag-ab-ultra-v2-0

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