BEUDAMED
    FDA Enforcement Class II Terminated

    VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.

    Recall: Z-1534-2021 · Reported May 12, 2021

    Enforcement

    Recall Number
    Z-1534-2021
    Event ID
    87660
    Classification
    Class II
    Status
    Terminated
    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
    May 12, 2021
    Initiation Date
    March 29, 2021
    Classification Date
    May 6, 2021
    Termination Date
    October 10, 2023
    Address
    4238 Capital Dr, N/A, Monroe, NC, 28110-7681, United States

    Description

    VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.

    Reason

    VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays.

    Code Info

    Item Number: 454322; Lot # A21023B5; UDI: (Case) 39120017574485 and (Rack) 29120017574488; Expiration Date: 02/06/2022 Item Number: 454332; Lot # A210338Q; UDI: (Case) 39120017574607 and (Rack) 29120017574600; Expiration Date: 03/01/2022 Item Number: 454334; Lot # A210233V; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/01/2022 Item Number: 454334; Lot # A21023XW; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/13/2022

    Distribution

    US Nationwide distribution in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MI, MO, NY, and NJ.

    Quantity

    1,049,700 units