BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component

    Recall: Z-0534-2026 · Reported November 26, 2025

    Enforcement

    Recall Number
    Z-0534-2026
    Event ID
    97763
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Quest International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2025
    Initiation Date
    October 1, 2025
    Classification Date
    November 17, 2025
    Address
    8127 Nw 29th St, Doral, FL, 33122-1051, United States

    Description

    Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma Component: not a component

    Reason

    Due to distributing the measles IgG IVD without a premarket approved/cleared.

    Code Info

    Lot Code: DI# 00850487007357 Lots affected: L07024 and E03025

    Distribution

    All products were distributed in the United States. (Utah, Washington).