BEUDAMED
    FDA Enforcement Class III Ongoing

    The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.

    Recall: Z-0805-2025 · Reported January 15, 2025

    Enforcement

    Recall Number
    Z-0805-2025
    Event ID
    95807
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Qualigen Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2025
    Initiation Date
    December 3, 2024
    Classification Date
    January 3, 2025
    Address
    2042 Corte Del Nogal, Ste B, Carlsbad, CA, 92011-1438, United States

    Description

    The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.

    Reason

    Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.

    Code Info

    UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26.

    Distribution

    Distribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN, TX, and VA. There was no military/government/foreign distribution.

    Quantity

    426