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Panther system

Official notice

13 Feb 2024

Last checked

13 Feb 2024

Medium riskHealth Canada
Watch Hologic

An official Health Canada notice concerns Panther system. 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 Published 2024-02-13.

What to do now

Company has notified customer of this situation, and allowed for software update.

Recall number

75066

Official notice

2024-02-13

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

75066

Lots

can

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Affected products

Product 1

Affected products - Panther System, Lot or serial number - Not applicable., Model or catalogue number - 303095

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Hologic, Panther System

Manufacturer

Not provided

Phone

Not provided

Brand: Hologic, Panther System.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75066

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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