# FDA recall Z-0595-2018

> **Hologic, Inc** · Class II · device recall initiated 2018-01-20.

## Product

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.

## Reason for recall

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

## Distribution

Worldwide distribution

## Key facts

- **Recall number:** Z-0595-2018
- **Recalling firm:** Hologic, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-20
- **Report date:** 2018-02-21
- **Termination date:** 2022-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0595-2018

## Citation

> AI Analytics. FDA recall Z-0595-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0595-2018. Source: US FDA. Licensed CC0.

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