BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

    Recall: Z-0571-2026 · Initiated August 19, 2025

    Recall

    Recall Number
    Z-0571-2026
    Event Number
    97499
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    JKA
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    August 19, 2025
    Posted
    November 19, 2025
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681

    Description

    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

    Reason

    Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

    Action

    On 08/22/2025, the firm sent via email an "Urgent Medical Device Correction" letter to customer informing them that some Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator which may affect the stability of the sample. Customers are instructed to: " Stop use immediately: Discontinue use of the affected product (concerned Item/Lot) and isolate it within your facility. " Notify staff and customers: Inform all relevant employees and notify all customers to whom you distributed the affected products. " Assess risk: Evaluate potential risks or consequences in accordance with your internal procedures and take appropriate action. " Confirm product disposition: Complete the attached Product Disposition Site Confirmation Form and return it via fax to 877-217-7927 or email to [email protected]. Confirmation is required that all affected products have been discarded/destroyed. Replacement products will be provided upon receipt of your completed form. For questions, call Greiner Bio-One Technical Service at 800-515-8112.

    Distribution

    U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY. O.U.S.: None

    Quantity

    1,980,000