Official recall record
Panther System
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-02-13
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
According to the assay package inserts for the following Aptima assays: HIV-1 Quant DX, HBV Quant, HCV Quant DX, CMV Quant, BV, and CV/TV, controls from different lot numbers can be used. However, Hologic has identified a software anomaly with Panther/Fusion SW version 7.2.9, where assay processing will not start when the control lots loaded on the Panther/Panther Fusion system do not match the ones listed on the control barcode sheet. Recall start date: November 17, 2023
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 2026-05-31.
Record last checked against the registry on 2026-05-31.
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