BEUDAMED
    FDA Enforcement Class II Ongoing

    Total Thyroxine (T4) ELISA; REF EIA-1781

    Recall: Z-0310-2022 · Reported December 8, 2021

    Enforcement

    Recall Number
    Z-0310-2022
    Event ID
    88949
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DRG International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 8, 2021
    Initiation Date
    October 18, 2021
    Classification Date
    November 29, 2021
    Address
    841 Mountain Ave, Springfield, NJ, 07081-3437, United States

    Description

    Total Thyroxine (T4) ELISA; REF EIA-1781

    Reason

    Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.

    Code Info

    lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021

    Distribution

    Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM

    Quantity

    314 total (270 US)