FDA recall Z-1092-2022

Product

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

Reason for recall

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

Distribution

US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None

Key facts

Status

Ongoing

Initiation date

2022-04-05

Report date

2022-05-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1092-2022