Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Vergene Amplification Tray - 700uL Recalled by Luminex Corporation Due to On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018)...

Date: December 26, 2018
Company: Luminex Corporation
Status: Terminated
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

Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.

Quantity: 1132 carriers

Why Was This Recalled?

On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.

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