FDA recall Z-1488-2021

Product

VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

Reason for recall

Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

Distribution

Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey.

Key facts

Status

Ongoing

Initiation date

2021-03-18

Report date

2021-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northbrook, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2021