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 SARS-CoV-2/Flu A/B/RSV Assay Recalled by Hologic, Inc. Due to SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2...

Date: November 8, 2024
Company: Hologic, Inc.
Status: Ongoing
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 SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

Quantity: 3

Why Was This Recalled?

SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

Where Was This Sold?

This product was distributed to 1 state: AK

Affected (1 state)Not affected

About Hologic, Inc.

Hologic, Inc. has 18 total recalls tracked by RecallDetector.

Related Recalls

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