BEUDAMED
    FDA Enforcement Class II Terminated

    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    Recall: Z-1388-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1388-2018
    Event ID
    79603
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Life Technologies Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    February 7, 2018
    Classification Date
    April 17, 2018
    Termination Date
    May 8, 2019
    Address
    7335 Executive Way, Frederick, MD, 21704-8354, United States

    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)

    Code Info

    Model # MHFH01 UDI (01)10190302005579(17)180430 (10)1626670D(240)MHFH01 Lot# 1626670D Model # MHFH01 UDI (01)10190302005579(17)190830 (10)1873068B(240)MHFH01 Lot# 1873068B Model # MHFH01 UDI (01)10190302005579(17)191030 (10)1915224B(240)MHFH01 Lot# 1915224B

    Distribution

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