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
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