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Luminex Corporation recalls VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIG
Recalled June 11, 2025 · FDA recall Z-1903-2025 · Luminex
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. · FDA Class II
Units
89 units
Sold at
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
Description
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.
Product
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
Manufacturer(s)
Luminex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →