FDA-Device2022-07-13Class II
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Luminex Corporation
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
Affected count
296 units
Manufactured in
4088 Commercial Ave, N/A, Northbrook, IL, United States
Products
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1334-2022Don't want to check this manually?
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