BEUDAMED
    FDA Enforcement Class II Terminated

    VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.

    Recall: Z-3027-2020 · Reported October 7, 2020

    Enforcement

    Recall Number
    Z-3027-2020
    Event ID
    86363
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greiner Bio-One North America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 7, 2020
    Initiation Date
    August 28, 2020
    Classification Date
    September 29, 2020
    Termination Date
    June 17, 2021
    Address
    4238 Capital Dr, N/A, Monroe, NC, 28110-7681, United States

    Description

    VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.

    Reason

    Blood collection tubes experienced an issue with separation and clotting

    Code Info

    Lot Number: B2003399

    Distribution

    US Nationwide distribution including in the states of IL, PA, VA, MO, NY.

    Quantity

    1,008,000 pieces