FDA recall Z-2024-2023

Product

VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

Reason for recall

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

Distribution

Worldwide and US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2023-06-05

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northbrook, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2024-2023