Recall Monitor
Health Products

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

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Immunology
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Aptima HIV-1 Quant Assayv2.0.0.97.0.5.7
Aptima HCV Quant Dx Assayv2.0.0.95.5.5.6
Aptima HBV Quant Assay Kit Softwarev2.0.0.95.4.5.5

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.

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