Monolisa Hcv Ag-Ab Ultra V2
Brand(s)
Last updated
Summary
Product
Monolisa Hcv Ag-Ab Ultra V2
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Monolisa Hcv Ag-Ab Ultra V2 |
3B1066 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
| Bio-Rad |
| 3 Boulevard Raymond Poincare, Marnes-La-Coquette, Marne, France, 92430 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74735
Get notified
Receive notifications for new and updated recalls and alerts by category.