BEUDAMED
    FDA Recall Terminated

    Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

    Recall: Z-0561-2022 · Initiated July 6, 2020

    Recall

    Recall Number
    Z-0561-2022
    Event Number
    89336
    Firm
    Gentueri Inc
    FEI Number
    3017528620
    Product Code
    JSM
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    July 6, 2020
    Terminated
    December 12, 2023
    Address
    312 Locust Dr, Verona, WI, 53593-2215

    Description

    Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

    Reason

    Kits failed sterility testing and showed evidence of contamination.

    Action

    The firm distributed a notice to customers dated 07/06/2020 via email stating that lots 1029, 1029A, and 1029B need to be quarantined pending further investigation. Customers with questions are asked to contact Renee Schlick, Quality Assurance Manager, at 608-838-1640 or by email at [email protected].

    Distribution

    Domestic: Illinois, Nebraska, and Wisconsin.

    Quantity

    13,975 units (2 mL in a 15 mL conical tube)