BEUDAMED
    FDA Enforcement Class II Terminated

    Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use

    Recall: Z-0171-2019 · Reported October 24, 2018

    Enforcement

    Recall Number
    Z-0171-2019
    Event ID
    81052
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Life Technologies, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2018
    Initiation Date
    August 24, 2018
    Classification Date
    October 17, 2018
    Termination Date
    April 29, 2020
    Address
    3175 Staley Rd, N/A, Grand Island, NY, 14072-2028, United States

    Description

    Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use

    Reason

    Leaky bottles due to a defect in the bottle cap compromising the sterility of the product

    Code Info

    Lot# 1986670 Exp.Date 30-Dec-2019. Lot# 1995631 Exp. Date 31-Jan-2020. UDI: 10190302001731

    Distribution

    Nationwide: Foreign: Argentina Australia Canada China Great Britain Hong Kong India Japan Mexico Netherlands New Zealand Singapore South Korea Taiwan

    Quantity

    1329 units