BEUDAMED
    FDA Enforcement Class II Terminated

    VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.

    Recall: Z-0818-2020 · Reported January 29, 2020

    Enforcement

    Recall Number
    Z-0818-2020
    Event ID
    84536
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greiner Bio-One North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 29, 2020
    Initiation Date
    November 25, 2019
    Classification Date
    January 17, 2020
    Termination Date
    October 5, 2020
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681, United States

    Description

    VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.

    Reason

    The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.

    Code Info

    DI: 29120049204476, Lot number B190338E

    Distribution

    Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA

    Quantity

    1,002,000 tubes