Luminex Corporation recalls Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product…

Recall date

June 15, 2020

Source

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

Recall number

Z-2775-2020

FDA classification

Class II

Brand / firm

Luminex Corporation

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CN, CT, DE, DC, FL,GA, ID, IN, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NB, NV, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN TX, UT, VT, VA, WA, WV, WY, and WI. The countr…

Why it was recalled

An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

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 Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.