Luminex Corporation recalls VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERI…

Recall date

April 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1903-2025

FDA classification

Class II

Brand / firm

Luminex Corporation

Sold / distributed

US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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