| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01051-1 |
| Product Name/Description |
Monolisa HCV Ag/Ab ULTRA V2?
Catalog number: 72561, 72562
UDIs: 03610520013762 & 03610520013779
Multiple Lot numbers and expiry dates.
ARTG 231015
(Bio-Rad Laboratories Pty Ltd - Monolisa HCV Ag-Ab ULTRA V2 - Hepatitis C virus antibody/antigen IVD, kit, enzyme immunoassay (EIA))
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
There has been an observation in the decrease of HCV antigen sensitivity for specimens that are near the limit of detection.
Due to this decrease in HCV antigen sensitivity, a recent HCV infection may not be detected in patient samples as early as prior batches of the Monolisa HCV Ag-Ab ULTRA V2 assay.
There is no impact to seroconversion observed for these batches through HCV antibody detection.
Early HCV infections are still detectable with positive HCV Antigen prior to HCV antibody assays (>12 days on average). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The Monolisa HCV Ag-Ab ULTRA V2 assay batches currently on the market can continue to be used as intended for detection of infection by HCV based on the detection of anti-HCV antibodies and capsid antigen in serum or human plasma, considering the decrease in HCV antigen sensitivity.
In case of suspected early HCV infection, customers must perform HCV NAT testing in addition to testing on the Monolisa HCV Ag-Ab ULTRA V2 assay as per the current IFU. |
| Contact Information |
1800224354 - Bio-Rad Laboratories Pty Ltd |