BEUDAMED
    FDA Enforcement Class III Terminated

    CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

    Recall: Z-1253-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1253-2019
    Event ID
    82017
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carolina Liquid Chemistries
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 8, 2019
    Initiation Date
    January 16, 2019
    Classification Date
    May 2, 2019
    Termination Date
    February 2, 2021
    Address
    313 Gallimore Dairy Rd, N/A, Greensboro, NC, 27409-9724, United States

    Description

    CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

    Reason

    Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.

    Code Info

    Lot 11687

    Distribution

    NY. NH, ME, NC, TX, AR, SC, CT, IL, CA, NJ

    Quantity

    20 kits