FDA recall Z-0054-2021

Luminex Corporation · Class II · device

Product

VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

Reason for recall

No results/incorrect results due to failure of the hybridization heater.

Distribution

US distribution in MO. No OUS

Key facts

Status
Ongoing
Initiation date
2018-12-10
Report date
2020-10-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0054-2021