BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1728-2020 · Initiated March 9, 2020

    Recall

    Recall Number
    Z-1728-2020
    Event Number
    85238
    Firm
    Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany
    FEI Number
    3002809144
    Product Code
    LOL
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 9, 2020
    Terminated
    February 11, 2021

    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.

    Action

    Abbott GmbH notified customers on 03/09/2020 via "Product Recall Urgent Immediate Action Required" letter. The recall letter identified the affected products and requested the customers to Immediately discontinue use of, and destroy, any remaining inventory of these ARCHITECT HAVABG reagent lots.

    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