BEUDAMED
    FDA Enforcement Class II Ongoing

    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

    Recall: Z-0408-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0408-2026
    Event ID
    97457
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Greiner Bio-One North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 5, 2025
    Initiation Date
    August 8, 2025
    Classification Date
    October 28, 2025
    Address
    4238 Capital Dr, N/A, Monroe, NC, 28110-7681, United States

    Description

    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

    Reason

    Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.

    Code Info

    UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026

    Distribution

    US Nationwide distribution.

    Quantity

    504,000