This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Monolisa Hcv Ag-Ab Ultra V2
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Monolisa Hcv Ag-Ab Ultra V2 | 3B1066 3A0065 | 72561 |
Issue
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
Additional information
Details
| Bio-Rad |
| 3 Boulevard Raymond Poincare, Marnes-La-Coquette, Marne, France, 92430 |
Get notified
Receive emails about new and updated recall and safety alerts.