FDA-Device2022-05-25Class II
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
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