FDA recall Z-0822-2019

Luminex Corporation · Class III · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-12-26
Report date
2019-02-20
Termination date
2020-08-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0822-2019