BEUDAMED
    FDA Recall Terminated

    Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP 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.

    Recall: Z-2735-2014 · Initiated June 17, 2013

    Recall

    Recall Number
    Z-2735-2014
    Event Number
    68014
    Firm
    Nanosphere, Inc.
    FEI Number
    3006028115
    Product Code
    PAM
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 17, 2013
    Posted
    September 30, 2014
    Terminated
    March 14, 2016
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP 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.

    Reason

    There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.

    Action

    Undated recall notification letters were sent to all direct accounts (customers) June 17 - 19, 2013. The letters included instructions for customers to: 1) check their inventory for the recalled products; 2) set any recalled products aside for return; and, 3) contact Nanosphere to obtain replacement tip holders. Customers with questions about this recall can contact Nanosphere via e-mail at [email protected] or by calling 888-837-4436.

    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.

    Quantity

    1,660 extraction trays