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Panther Fusion® GBS Assay
Brand(s)
Last updated
Summary
Product
Panther Fusion® GBS Assay
Issue
Medical devices - Performance
What to do
Customer notification. Stop using affected devices, and discard them.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Panther Fusion® GBS Assay | Kit Lot 715927, Cartridge Lot 624907 | PRD-04484 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
| Hologic, Inc. |
| 10210 Genetic Center Drive, San Diego, California, United States, 92121 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76772
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