BEUDAMED
    FDA Recall Open, Classified

    Yeastone Broth, 11ML, 10/BOX YY3462

    Recall: Z-1806-2026 · Initiated March 24, 2026

    Recall

    Recall Number
    Z-1806-2026
    Event Number
    98616
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    NGZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 24, 2026
    Posted
    April 10, 2026
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    Firm began notifying consignees on March 24, 2026 via letters titled "Urgent: Medical Device Recall." Customers were informed that the affected products may report incorrect AST results during quality control. Customers were asked to notify any personnel who need to be aware of the issue. Laboratory professionals are advised to review previously reported susceptibility results generated using affected lots and assess whether retesting is appropriate. Remaining inventory of affected lots must be destroyed; these lots should not be used for any clinical laboratory testing. The firm is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.

    Distribution

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

    Quantity

    2819