FDA-Device2025-06-11Class II
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Luminex Corporation
Hazard
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
Sold states
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
Affected count
89 units
Manufactured in
4088 Commercial Ave, N/A, Northbrook, IL, United States
Products
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1903-2025Don't want to check this manually?
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