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 Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL Recalled by Luminex Corporation Due to Higher than normal "No Call Internal Control failures"...

Date: February 15, 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 Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

Quantity: 984 units

Why Was This Recalled?

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

Where Was This Sold?

US

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