Official recall record
Monolisa Hcv Ag-Ab Ultra V2
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-12-14
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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