BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2236-2014 · Initiated July 9, 2014

    Recall

    Recall Number
    Z-2236-2014
    Event Number
    68831
    Firm
    Nanosphere, Inc.
    FEI Number
    3006028115
    Product Code
    PEN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 9, 2014
    Posted
    August 14, 2014
    Terminated
    September 1, 2015
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    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.

    Reason

    Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.

    Action

    Nanosphere sent an Urgent Product Recall letter dated July 9, 2014 to all affected customers. All customers were initially notified of the recall by telephone on July 9, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere. The letter included instructions: 1) on how to return the recalled products, and 2) to review any test results that were generated while using the recalled products to ensure that there has been no negative impact on patient care. Customers with questions were instructed to contact Nanosphere at 888-837-4436, option 2 or via e-mail at [email protected].

    Distribution

    Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT

    Quantity

    1045 extraction trays (840 affected by recall)