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Luminex Corporation recalls Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Tes
Recalled February 20, 2019 · FDA recall Z-0822-2019 · Luminex
Hazard
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label. · FDA Class III
Units
1132 carriers
Sold at
Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.
Description
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
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.
Manufacturer(s)
Luminex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →