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Panther fusion® gbs assay

Official notice

30 Dec 2024

Last checked

30 Dec 2024

Medium riskHealth Canada
Watch Hologic

An official Health Canada notice concerns Panther fusion® gbs assay. Hologic identified that the reagents, or "pearls", in the Panther Fusion cartridges exhibited abnormalities. Fusion cartridges are susceptible to moisture ingress via vapor transmission as a result of incomplete seals of the cartridge foil and of the flow wrap foil pouch. Recall start date: December 16, 2024 Published 2024-12-30.

What to do now

Customer notification. Stop using affected devices, and discard them.

Recall number

76772

Official notice

2024-12-30

The hazard

Hologic identified that the reagents, or "pearls", in the Panther Fusion cartridges exhibited abnormalities. Fusion cartridges are susceptible to moisture ingress via vapor transmission as a result of incomplete seals of the cartridge foil and of the flow wrap foil pouch. Recall start date: December 16, 2024

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

76772

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Affected products

Product 1

Affected products - Panther Fusion® GBS Assay, Lot or serial number - Kit Lot 715927, Cartridge Lot 624907, Model or catalogue number - PRD-04484

Risk / hazard

Hologic identified that the reagents, or "pearls", in the Panther Fusion cartridges exhibited abnormalities. Fusion cartridges are susceptible to moisture ingress via vapor transmission as a result of incomplete seals of the cartridge foil and of the flow wrap foil pouch. Recall start date: December 16, 2024

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 Fusion® Gbs Assay

Manufacturer

Not provided

Phone

Not provided

Brand: Hologic, Panther Fusion® Gbs Assay.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76772

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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