CanadaAptima HIV Quant Dx Assay, Aptima HCV Quant Dx Assay, and Aptima HBV Quant Assay software (assay installer version v2.0.0.9; model numbers 7.0.5.7, 5.5.5.6, 5.4.5.5) installed on Panther and Panther Fusion systems are affected. The software was installed prior to Health Canada approval, although the notice states it has been validated and released and that the configuration does not affect assay performance or test result accuracy. Customers will be contacted with instructions to follow.
What's being recalled
Companies: Hologic, Inc., 10210 Genetic Center Drive, San Diego, California, United States, 92121.
How to identify it
Affected products: Aptima HIV-1 Quant Assay; Lot or serial number: v2.0.0.9; Model or catalogue number: 7.0.5.7
Affected products: Aptima HCV Quant Dx Assay; Lot or serial number: v2.0.0.9; Model or catalogue number: 5.5.5.6
Affected products: Aptima HBV Quant Assay Kit Software; Lot or serial number: v2.0.0.9; Model or catalogue number: 5.4.5.5
The hazard
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.
What to do
Customers will be contacted with instructions to follow.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States