Luminex Corporation recalls Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test…

Recall date

December 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0822-2019

FDA classification

Class III

Brand / firm

Luminex Corporation

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.