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 Processor SP Recalled by Luminex Corporation Due to Heater within the Verigene System may be outside...

Date: April 5, 2022
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 Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

Quantity: 24 units

Why Was This Recalled?

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

Where Was This Sold?

This product was distributed to 16 states: AZ, CA, CO, FL, GA, IL, IN, KY, ME, MI, NE, OH, PA, TX, VT, WA

Affected (16 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