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Health Canada Medical devices

Panther System

Issued February 13, 2024
Issue
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
Hazard description
Performance
Product
Product name
Panther System
Reference
ID
RA-75066