BEUDAMED
    FDA Enforcement Class II Ongoing

    Yeastone Broth, 11ML, 10/BOX YY3462

    Recall: Z-1806-2026 · Reported April 22, 2026

    Enforcement

    Recall Number
    Z-1806-2026
    Event ID
    98616
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remel, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2026
    Initiation Date
    March 24, 2026
    Classification Date
    April 10, 2026
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Yeastone Broth, 11ML, 10/BOX YY3462

    Reason

    Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.

    Code Info

    UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.

    Quantity

    2819