BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0171-2019 · Initiated August 24, 2018

    Recall

    Recall Number
    Z-0171-2019
    Event Number
    81052
    Firm
    Life Technologies, Corp.
    FEI Number
    1317268
    Product Code
    KIT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 24, 2018
    Terminated
    April 29, 2020
    Address
    3175 Staley Rd, Grand Island, NY, 14072-2028

    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

    Action

    Thermo Fisherr issued Urgent Medical Device Recall Notification Letter with a customer response sheet sent to consignees via FedEx on 24-Aug-2018. Consignees have been instructed to discard affected product per local and state requirements, or return the affected product to Thermo Fisher Scientific. All consignees are instructed to complete the attached Customer Response Sheet. Thermo Fisher Scientific will issue a no-cost replacement for the recalled product. In addition, consignees are instructed to review results and laboratory reporting associated with use of the affected product for further action. Consignees should notify any personnel who need to be aware of the potential for failure of performance for this product. Questions: contact Technical Services Department at 800-955-6288 Option 2.

    Distribution

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

    Quantity

    1329 units