medical Class III Updated 2019-02-20

Luminex Corporation recalls Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00857573006287, Lots: 110318018C, 111018018D
View official government recall

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