BEUDAMED
    FDA Enforcement Class II Ongoing

    Verigene CDF Nucleic Acid Test, Part No. 30-002-22

    Recall: Z-1334-2022 · Reported July 13, 2022

    Enforcement

    Recall Number
    Z-1334-2022
    Event ID
    90122
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2022
    Initiation Date
    June 17, 2022
    Classification Date
    July 6, 2022
    Address
    4088 Commercial Ave, N/A, Northbrook, IL, 60062-1829, United States

    Description

    Verigene CDF Nucleic Acid Test, Part No. 30-002-22

    Reason

    There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.

    Code Info

    UDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946; Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850; Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.

    Quantity

    296 units