Health Canada11 Jun 2026
Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software
Health Canada published a recall notice for Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software on 11 Jun 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 11 Jun 2026
- Recall type
- Health product recall
- Companies
- Hologic, Inc.10210 Genetic Center Drive, San Diego, California, United States, 92121
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: This notification is to inform Panther and Panther Fusion users that assay installer (version 2.0.0.9) including the Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay software was installed on Panther and Panther Fusion systems prior to Health Canada approval.The Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay software included in assay installer version 2.0.0.9 have not been approved by Health Canada but have been validated and released. Based on this, the configuration does not affect assay performance, compromise the accuracy of test results, or impact product performance. Additional information Details Original published date: 2026-06-11 Affected products: Affected products Lot or serial number Model or catalogue number Aptima HIV-1 Quant Assay v2.0.0.9 7.0.5.7 Aptima HCV Quant Dx Assay v2.0.0.9 5.5.5.6 Aptima HBV Quant Assay Kit Software v2.0.0.9 5.4.5.5 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.