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.
Enforcement
- Recall Number
- Z-0822-2019
- Event ID
- 81890
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Luminex Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- February 20, 2019
- Initiation Date
- December 26, 2018
- Classification Date
- February 11, 2019
- Termination Date
- August 4, 2020
- Address
- 12212 Technology Blvd, N/A, Austin, TX, 78727-6101, United States
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.
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
UDI: 00857573006287, Lots: 110318018C, 111018018D
Worldwide Distribution: US (nationwide) and countries of: Austria, and Italy.
1132 carriers