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 Model No. 10-0000-07. An in vitro diagnostic Recalled by Luminex Corporation Due to No results/incorrect results due to failure of the...

Date: December 10, 2018
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 Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

Quantity: 1 system

Why Was This Recalled?

No results/incorrect results due to failure of the hybridization heater.

Where Was This Sold?

This product was distributed to 1 state: MO

Affected (1 state)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