BEUDAMED
    FDA Enforcement Class II Terminated

    Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;

    Recall: Z-1077-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1077-2018
    Event ID
    79364
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Epigenomics Ag
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 28, 2018
    Initiation Date
    November 2, 2017
    Classification Date
    March 16, 2018
    Termination Date
    June 19, 2018
    Address
    Geneststr. 5, N/A, Berlin, N/A, N/A, Germany

    Description

    Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;

    Reason

    The diagnostic test kit may produce invalid test runs which may delay test results.

    Code Info

    Lot Number: 16903908; Expiration Date: 28 Feb 2018

    Distribution

    Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.

    Quantity

    200