BEUDAMED
    FDA Recall Terminated

    T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.

    Recall: Z-0214-2022 · Initiated October 14, 2021

    Recall

    Recall Number
    Z-0214-2022
    Event Number
    88869
    Firm
    BioCheck, Inc.
    FEI Number
    3002564473
    Product Code
    KLI
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    October 14, 2021
    Posted
    November 10, 2021
    Terminated
    February 14, 2025
    Address
    425 Eccles Ave, South San Francisco, CA, 94080-1902

    Description

    T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.

    Reason

    Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

    Action

    On October 14, 2021 BioCheck issued a "Medical Device Recall Notification" to affected customers. In addition to informing consignees about the recall, BioCheck asked consignees to take the following actions: 1) Please immediately discontinue use or distribution of the affected lots. 2) If you have further distributed the affected product lots, please identify those customers and notify them at once of this product recall. 3) If you have relabeled or rebranded the affected product lots, please follow your internal recall process and notify appropriate regulatory bodies, if required. 4) Disposal of all affected lots should be in accordance with applicable national, state, and local laws and regulations. 5) Complete and return the enclosed Return Response Form by October 29, 2021 to BioCheck, Inc,, 425 Eccles Avenue, South San Francisco, CA 94080 or email to: [email protected] as is required to meet subsequent FDA Status Reporting requirements. CUSTOMER CREDIT 8. Upon receipt of completed Return Response Form, customer's account will be credited for the identified products that are disposed of. If you have any questions, contact Director QA/RA at (650) 573-1968 or email: [email protected].

    Distribution

    US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria

    Quantity

    314 kits