BEUDAMED
    FDA Enforcement Class II Ongoing

    EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

    Recall: Z-0426-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0426-2021
    Event ID
    86516
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Epitope Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2020
    Initiation Date
    October 1, 2020
    Classification Date
    November 6, 2020
    Address
    7110 Carroll Rd, San Diego, CA, 92121-2215, United States

    Description

    EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

    Reason

    The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

    Code Info

    Lot Numbers: P826, P815, P796, P776

    Distribution

    U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.

    Quantity

    2886