FDA recall Z-0920-2022

Product

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

Reason for recall

Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.

Distribution

US: TX, CT, LA

Key facts

Status

Ongoing

Initiation date

2019-04-22

Report date

2022-04-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northbrook, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0920-2022