Hologic, Inc recalls Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated samp…

Recall date

January 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0595-2018

FDA classification

Class II

Brand / firm

Hologic, Inc

Sold / distributed

Worldwide distribution

Why it was recalled

The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.