BEUDAMED
    FDA Enforcement Class II Terminated

    Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent

    Recall: Z-1743-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1743-2020
    Event ID
    85229
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carolina Liquid Chemistries Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 29, 2020
    Initiation Date
    January 20, 2020
    Classification Date
    April 17, 2020
    Termination Date
    January 14, 2021
    Address
    510 W Central Ave Ste C, N/A, Brea, CA, 92821-3032, United States

    Description

    Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent

    Reason

    Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes

    Code Info

    Lots: H1801, C1942, D1945, H1901, H1933, L1909

    Distribution

    U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA

    Quantity

    90 test kits/devices