BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2552-2025 · Initiated July 17, 2025

    Recall

    Recall Number
    Z-2552-2025
    Event Number
    97419
    Firm
    Quest International, Inc.
    FEI Number
    3000206132
    Product Code
    PCL
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    July 17, 2025
    Posted
    September 11, 2025
    Address
    8127 Nw 29th St, Doral, FL, 33122-1051

    Description

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

    Reason

    Measles IgM Test Kit lacks premarket approval or clearance.

    Action

    On July 17, 2025, Quest International, Inc. issued a "Urgent: Medical Device Recall Notification to affected consignees via E-Mail. Quest International asked consignees to take the following actions: 1. Please examine your inventory and quarantine the affected lot. In addition, if you have distributed the product, you must identify all customers that have received the affected product and immediately notify them. 2. Please ask your customers to discontinue the use of the affected product(s) lot of the Measles IgM Test Kit immediately. 3. We ask that you and your customers discard all affected products in accordance with all local, state, and federal disposal procedures. 4. Please complete and return the enclosed Medical Device Recall Response Form as soon as possible.

    Distribution

    US Nationwide distribution in the states of Utah, Texas, and Arizona.

    Quantity

    376 kits