Device Recall Nanosphere Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN)

Part Number: 20-009-021; Lot Numbers: 052113021C

Immunology and Microbiology Devices

2

No

Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.

Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.