BEUDAMED
    FDA Enforcement Class II 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 · Reported October 8, 2014

    Enforcement

    Recall Number
    Z-2735-2014
    Event ID
    68014
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nanosphere, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 8, 2014
    Initiation Date
    June 17, 2013
    Classification Date
    September 30, 2014
    Termination Date
    March 14, 2016
    Address
    4088 Commercial Ave, N/A, Northbrook, IL, 60062-1829, United States

    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.

    Code Info

    Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C

    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