BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1253-2019 · Initiated January 16, 2019

    Recall

    Recall Number
    Z-1253-2019
    Event Number
    82017
    Firm
    Carolina Liquid Chemistries
    FEI Number
    3009880320
    Product Code
    DIC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 16, 2019
    Terminated
    February 2, 2021
    Address
    313 Gallimore Dairy Rd, Greensboro, NC, 27409-9724

    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.

    Action

    The firm initiated the recall by email on 01/16/2019. The notice requested that the consignee discard the product.

    Distribution

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

    Quantity

    20 kits