BEUDAMED
    FDA Recall Open, Classified

    Total Thyroxine (T4) ELISA; REF EIA-1781

    Recall: Z-0310-2022 · Initiated October 18, 2021

    Recall

    Recall Number
    Z-0310-2022
    Event Number
    88949
    Firm
    DRG International, Inc.
    FEI Number
    2245285
    Product Code
    KLI
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 18, 2021
    Address
    841 Mountain Ave, Springfield, NJ, 07081-3437

    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.

    Action

    On 10/18/2021, DRG issued Medical Device Recall Notification letters and response forms to the End-user through confirmation of the Distributor. All customers were notified via e-mail. Actions Required: 1) Please immediately discontinue use or distribution of the affected lots. 2) If you have further distributed the affected product lots, please identify and immediately notify those customers at once of this product recall by providing a copy of the recall notice and response form. 3) If you have relabeled or rebranded the affected product lots, please follow your internal recall process and notify the appropriate regulatory bodies as required. 4) Disposal of all affected lots should be in accordance with applicable national, st ate, and local laws and regulations. 5) Complete and return the response form.

    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)