BEUDAMED
    FDA Recall 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 · Initiated November 25, 2019

    Recall

    Recall Number
    Z-0818-2020
    Event Number
    84536
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 25, 2019
    Terminated
    October 5, 2020
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681

    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.

    Action

    The firm initiated the recall by email on 11/25/2019. The letter explained the problem and requested the consignees cease distribution and provide a list of their customers for Greiner to contact. The firm is seeking return or on site destruction of the affected product.

    Distribution

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

    Quantity

    1,002,000 tubes