Official recall record

Aptima HIV Quant Dx Assay, HCV Quant Dx Assay, and HBV Quant Assay Software

Health Canada — Medical Devices · 2026-06-11 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2026-06-11
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-06-21.

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