BEUDAMED
    FDA Recall Terminated

    Gentueri Viral Transport Medium (VTM), Sterile, IVD

    Recall: Z-0504-2022 · Initiated March 18, 2021

    Recall

    Recall Number
    Z-0504-2022
    Event Number
    89337
    Firm
    Gentueri Inc
    FEI Number
    3017528620
    Product Code
    JSM
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    March 18, 2021
    Terminated
    August 28, 2023
    Address
    312 Locust Dr, Verona, WI, 53593-2215

    Description

    Gentueri Viral Transport Medium (VTM), Sterile, IVD

    Reason

    Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.

    Action

    The firm called the customer on 03/19/2021 and indicated that there was a possible contamination of Lot 1142 and that this needed to be held at distribution facilities. Following the conversation, Gentueri emailed as an attachment a "Removal Notification," for VTM Lot 1142 that explained that the lot failed to pass inspection and all product from this lot at the customer's site needed to be returned. Customers with any questions are to contact Gordon S. Hunter, Marketing Manager for Gentueri, at [email protected] or 1-608-497-0366.

    Distribution

    US Nationwide distribution in the state of Indiana.

    Quantity

    4,150 units