BEUDAMED
    FDA Enforcement Class III Terminated

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    Recall: Z-1256-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1256-2019
    Event ID
    82011
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lin-Zhi International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 8, 2019
    Initiation Date
    January 11, 2019
    Classification Date
    May 2, 2019
    Termination Date
    March 22, 2021
    Address
    2945 Oakmead Village Ct, N/A, Santa Clara, CA, 95051-0812, United States

    Description

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    Reason

    Shelf life of the product may be reduced due to degradation of the assay.

    Code Info

    (a) REF 0220 (small test kit), Lot Code 1810026 (b) REF 0221 (large test kit), Lot Code 1810025

    Distribution

    US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR

    Quantity

    49 kits