Luminex Corporation recalls VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnos…

Recall date

September 14, 2018

Source

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

Recall number

Z-0445-2019

FDA classification

Class II

Brand / firm

Luminex Corporation

Sold / distributed

Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France

Why it was recalled

Potential to lead to a false negative results.

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 Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.