FDA-Device2022-05-25Class II
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Luminex Corporation
Hazard
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Sold states
US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
Affected count
24 units
Manufactured in
12212 Technology Blvd, N/A, Austin, TX, United States
Products
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1092-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief