BEUDAMED
    FDA Recall Terminated

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    Recall: Z-0477-2021 · Initiated October 13, 2020

    Recall

    Recall Number
    Z-0477-2021
    Event Number
    86124
    Firm
    Luminex Corporation
    FEI Number
    3006028115
    Product Code
    PEN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 13, 2020
    Terminated
    January 22, 2024
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    Reason

    Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.

    Action

    On 10/13/2020, the firm sent the following notice: "As part of our corrective action plan, Luminex will be updating software on all VERIGENE SP instruments in the coming weeks, and systematically visiting every VERIGENE customer site to perform a supplemental preventative maintenance on your instruments. We will also likely be sending out a series of Customer Advisory Notifications with additional information on items related to our remediation efforts surrounding the Warning Letter, as well as updates related to other items identified for improved product performance. During this time, you may continue to use your VERIGENE products as directed in the package inserts for each product, or as otherwise directed through further Luminex communications. If you have any question, please do not hesitate to contact Luminex Global Support Services using the contact details below: Luminex Global Support Services 1-877-785-2323 (U.S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) [email protected]"

    Distribution

    Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey

    Quantity

    2838 units