BEUDAMED
    FDA Recall Terminated

    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    Recall: Z-1388-2018 · Initiated February 7, 2018

    Recall

    Recall Number
    Z-1388-2018
    Event Number
    79603
    Firm
    Life Technologies Corporation
    FEI Number
    3003335080
    Product Code
    GHQ
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    February 7, 2018
    Terminated
    May 8, 2019
    Address
    7335 Executive Way, Frederick, MD, 21704-8354

    Description

    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    Reason

    Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.e. false positives)

    Action

    All consignees which have purchased the Human Fetal Hemoglobin FITC antibody including facilities/customers that have shipped the lots outside of their facility will be notified via certified mail to check inventory to see if affected product is on hand. Consignees instructed to discontinue use and discard per internal procedure. The effectiveness check will begin 10 days after the distribution date of the Medical Device Recall Notification. The field removal is considered effective when 10% of the affected customers acknowledge receipt and understanding of the notification instructions.

    Distribution

    MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA