BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1743-2020 · Initiated January 20, 2020

    Recall

    Recall Number
    Z-1743-2020
    Event Number
    85229
    Firm
    Carolina Liquid Chemistries Corp
    FEI Number
    3000215862
    Product Code
    DJG
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 20, 2020
    Terminated
    January 14, 2021
    Address
    510 W Central Ave, Ste C, Brea, CA, 92821-3032

    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

    Action

    On 01/20/20 Immediate Action Required notifications were emailed to customers inquiring about the disposition of discontinued products; whether they had been used, if there was remaining inventory. Customers were asked to fill out and return the Immediate Action Required form. Customers were provided with the following contact information: 336-722-8910 and carolinachemistries.com

    Distribution

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

    Quantity

    90 test kits/devices