FDA-Device2021-05-05Class II
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
Luminex Corporation
Hazard
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.
Sold states
Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, Turkey.
Affected count
1210 Units
Manufactured in
4088 Commercial Ave, N/A, Northbrook, IL, United States
Products
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2021Don't want to check this manually?
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