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(R) System Recalled by Hologic, Inc Due to An incorrect incubator was installed on one Panther...

Date: September 15, 2017
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(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

Quantity: 1 unit

Why Was This Recalled?

An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.

Where Was This Sold?

Indiana

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