FDA recall Z-1335-2022

Product

VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

Reason for recall

There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

Distribution

Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.

Key facts

Status

Ongoing

Initiation date

2022-06-17

Report date

2022-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northbrook, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1335-2022