Devices

Device Recall Nanosphere Verigene

  • Model / Serial
    VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
  • Product Description
    Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
  • Manufacturer
    Nanosphere, Inc.
  • 1 Event

Manufacturer

Nanosphere, Inc.
  • Manufacturer Address
    Nanosphere, Inc., 4088 Commercial Ave, Northbrook IL 60062-1829
  • Manufacturer Parent Company (2017)
    Luminex Corporation
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test
  • Model / Serial
    (Catalog No. 20-005-019)    Kit Numbers (US Distribution): 051013019-9, 6288-1, 6547-1, 6420-1, 5478-1, 5802-1, 6190-1, 7360-3, 5452-2, 6499-1, 6414-1, 7183-1, 7511-1, 5225-1, 5225-2, 6495-1, 5760-1, 5779-1, 7259-1, 6783-1, 7435-1    Kit Numbers (Foreign Distribution): 7300-4, 5500-1, 5908-3, 5970-3, 6402-1, 6402-2, 6105-1, 6123-1, 6793-1, 6827-1, 6224-1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.
  • Product Description
    Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
  • Manufacturer
    Nanosphere, Inc.
Device Recall Nanosphere Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN)
  • Model / Serial
    Part Number: 20-009-021; Lot Numbers: 052113021C
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
    Nanosphere, Inc.