Product Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software Issue Medical devices - Unauthorised device What to do Customers will be contacted with instructions to follow. Audience Healthcare
Hazard description
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.
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