BEUDAMED
    FDA Enforcement Class II Terminated

    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

    Recall: Z-1728-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1728-2020
    Event ID
    85238
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Gmbh & Co. KG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    March 9, 2020
    Classification Date
    April 17, 2020
    Termination Date
    February 11, 2021
    Address
    Max-Planck-Ring 2, 65205, Wiesbaden, N/A, N/A, Germany

    Description

    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

    Reason

    An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.

    Code Info

    List Number 6L27 25. Lot No: 03429BE00, 06172BE00, 08073BE00, 10353BE00. UDI: (01)00380740011185 (17)200320(10)03429BE00, (01)00380740011185 (17)200604(10)06172BE00, (01)00380740011185 (17)200819(10)08073BE00, (01)00380740011185 (17)201023(10)10353BE00.

    Distribution

    US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR.

    Quantity

    7,347 kits