Class II — Potential Health Hazard

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

Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: Recalled by Luminex Corporation Due to Potential for a false-negative result.

Date: October 30, 2020
Company: Luminex Corporation
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 Luminex Corporation directly.

Affected Products

Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

Quantity: 1,261

Why Was This Recalled?

Potential for a false-negative result.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Luminex Corporation

Luminex Corporation has 39 total recalls tracked by RecallDetector.

Related Recalls

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