Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Panther Fusion Tube Tray Recalled by Hologic, Inc Due to Tube trays may leak which could invalidate patient...

Date: August 4, 2020
Company: Hologic, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc directly.

Affected Products

Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

Quantity: 607

Why Was This Recalled?

Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.

Where Was This Sold?

This product was distributed to 26 states: AL, CA, CO, CT, DE, FL, GA, HI, ID, IL, ME, MA, NJ, NY, NC, OK, OR, SC, TN, TX, UT, VT, VA, WA, WI, DC

Affected (26 states)Not affected

About Hologic, Inc

Hologic, Inc has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report