BEUDAMED
    FDA Recall Completed

    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003

    Recall: Z-1583-2023 · Initiated March 31, 2023

    Recall

    Recall Number
    Z-1583-2023
    Event Number
    92025
    Firm
    Greiner Bio-One North America, Inc.
    FEI Number
    3001451379
    Product Code
    JKA
    Status
    Completed
    Root Cause
    Labeling Change Control
    Initiated
    March 31, 2023
    Posted
    May 12, 2023
    Address
    4238 Capital Dr, Monroe, NC, 28110-7681

    Description

    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003

    Reason

    Some of the tubes may be incorrectly labeled.

    Action

    The recalling firm issued a letter dated 3/30/2023 on 3/31/2023 via email to their sole customer. The letter provided the reason for recall, contained detailed information regarding the complaint, provided photographs of the product which included incorrect tube labels and correct tube labels, investigation results, health risk analysis, and actions to be taken. Those actions included to discontinue use of the product immediately and isolate it, assess the risks and consequences of the use of the defective product in accordance with the customer's procedures and take appropriate action, and complete the attached Product Disposition Site Confirmation. The customer is to record the amount of product they have destroyed on the form and return it via FAX or email. It also instructs that if the customer has distributed this product elsewhere, they are requested to provide the recalling firm with the contact information for follow-up.

    Distribution

    US Nationwide distribution in the states of WI and GA.

    Quantity

    36,000 pieces (30 full cases)