BEUDAMED
    FDA Enforcement Class III Terminated

    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    Recall: Z-3004-2020 · Reported September 30, 2020

    Enforcement

    Recall Number
    Z-3004-2020
    Event ID
    86279
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    DNA Genotek Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2020
    Initiation Date
    June 24, 2020
    Classification Date
    September 23, 2020
    Termination Date
    November 1, 2021
    Address
    3000-500 Palladium Dr, N/A, Kanata, N/A, N/A, Canada

    Description

    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    Reason

    Reagents were shipped to customers after the Use by data indicated on its labeling.

    Code Info

    Lot PT-Q2A WE11

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.

    Quantity

    74