Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood C...
FDA Recall #Z-0822-2019 — Class III — December 26, 2018
Product Description
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.
Reason for Recall
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
Recalling Firm
Luminex Corporation — Austin, TX
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
1132 carriers
Distribution
Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.
Code Information
UDI: 00857573006287, Lots: 110318018C, 111018018D
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated