FDA recall Z-1334-2022

Luminex Corporation · Class II · device

Product

Verigene CDF Nucleic Acid Test, Part No. 30-002-22

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-1334-2022